Breath analysis cartridge with components for dispensing developer solution

ABSTRACT

Various systems, devices, components, and methods are disclosed for measuring the concentration of an analyte, such as acetone, in a breath sample. The disclosed devices include a breath sample analysis device having a mouthpiece configured to facilitate engagement with a user&#39;s mouth to receive a breath sample. The disclosed devices also include a breath sample capture cartridge containing an interactant that extracts the analyte from a breath sample passed through the cartridge. Also disclosed are devices for routing the breath sample through the cartridge during exhalation, and for analyzing a reaction in the cartridge to measure a concentration of the analyte.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-provisional patentapplication Ser. No. 17/725,436, filed Apr. 20, 2022, titled Systems,Devices, Components and Methods for Breath Analysis which claimspriority to U.S. Provisional Patent Application No. 63/261,098 filedSep. 10, 2021, titled Systems, Devices, Components and Methods forBreath Analysis, the entire contents of each of which are incorporatedby reference herein in their entirety and for all purposes.

BACKGROUND

Field

The present disclosure relates to systems, devices, components, andmethods for sensing or measuring chemical components or constituents(e.g., analytes) in the breath of a patient or “subject,” and preferablyendogenous analytes in breath, and correspondingly, to systems, devices,components, and methods for regulating the flow of the breath sampleduring the pre-measurement capture process and/or during such sensing ormeasurement.

Description of the Related Art

The importance or benefits of measuring the presence or concentration ofchemical constituents in the body to aid in assessing a patient orsubject's physiological or pathophysiological state is well known in themedical and diagnostic communities. Standard approaches tochemically-based diagnostic screening and analysis typically involveblood tests and urine tests.

Blood tests of course require that blood be drawn. Patients associatethis procedure with pain, a factor that can have adverse implicationsfor patient compliance in home-based assessments. In clinical settings,the need to draw blood typically requires trained personnel to draw theblood, carefully and properly label it, handle it and the like. It istypically necessary to transport the sample to a laboratory, often offsite, for analysis. Given the logistics and economics, the lab analysisusually is carried out in bulk on large numbers of samples, thusrequiring bulk handling and logistics considerations and introducingdelay into the time required to obtain results. It is then typicallynecessary for follow-up analysis by the physician or clinician to assessthe lab results and further communicate with the patient. In large partbecause of these logistics and delays, it is usually necessary for thepatient or subject to return for a follow up visit, thus takingadditional clinical time and causing additional expense.

Urine tests involve similar drawbacks. Such tests can be messy,unsanitary, and introduce issues with respect to labeling, handling andcontamination avoidance. They also usually involve lab analysis, withassociated delays and expense. As with blood, with urine tests it istypically necessary to transport the samples to an off-site laboratoryfor analysis. Given the logistics, the lab analysis usually is carriedout in bulk on large numbers of samples, thus again involving delay andexpense.

There are many instances in which it is desirable to sense the presenceand/or quantity or concentration of an analyte in a gas. “Analyte” asthe term is used herein is used broadly to mean the chemical componentor constituent that is sought to be sensed using devices, components,and methods according to various aspects of the disclosure. An analytemay be or comprise an element, compound or other molecule, an ion ormolecular fragment, or other substance that may be contained within afluid. In some instances, embodiments and methods, there may be morethan one analyte present, and an objective is to sense multipleanalytes. “Gas” as the term is used herein also is used broadly andaccording to its common meaning to include not only pure gas phases butalso vapors, non-liquid fluid phases, gaseous colloidal suspensions,solid phase particulate matter or liquid phase droplets entrained orsuspended in gases or vapors, and the like. “Sense” and “sensing” as theterms are used herein are used broadly to mean detecting the presence ofone or more analytes, or to measure the amount or concentration of theone or more analytes.

The use of breath as a source of chemical analysis can overcome many ofthese drawbacks. The presence of these analytes in breath and theirassociated correlations with physiological or pathophysiological statesoffer the substantial theoretical or potential benefit of providinginformation about the underlying or correlated physiological orpathophysiological state of the subject, in some cases enabling one toscreen, diagnose and/or treat a patient or subject easily and costeffectively. Breath analysis can avoid painful invasive techniques suchas with blood tests, and messy and cumbersome techniques such as urineanalysis. Moreover, in many applications test results can be obtainedpromptly, e.g., during a single typical patient exam or office visit,and cost effectively.

As is well known in the field of pulmonology, breath, and particularlybreath exhalations, comprise a range of chemical components, oranalytes. An “analyte” is a chemical component or constituent that is acandidate for sensing, detection or measurement. Breath compositionvaries somewhat from subject to subject, and within a given subject,from time to time, depending on such factors as physical condition(e.g., weight, body composition), diet (e.g., general diet, recentintake of food, liquids, etc.), exertion level (e.g., resting metabolicrate versus under stress or exercise), and pathology (e.g., diseasedstate). Approximately 200 to 300 analytes can be found in human breath.

Certain breath analytes have been correlated with specific physiologicalor pathophysiological states. Such correlations are particularly usefulfor “endogenous” analytes (i.e., those that are produced by the body),as opposed to “exogenous” analytes (i.e., those that are present inbreath strictly as a result of inhalation, ingestion or consumption andsubsequent exhalation by the subject). Examples are set forth in Table1.

TABLE 1 Candidate Analyte Illustrative Pathophysiology/Physical StateAcetone Lipid metabolism (e.g., epilepsy management, nutritionalmonitoring, weight loss therapy, early warning of diabeticketoacidosis), environmental monitoring, acetone toxicity, congestiveheart failure, malnutrition, exercise, management of eating disordersEthanol Alcohol toxicity, bacterial growth Acetaldehyde Ammonia Liver orrenal failure, protein metabolism, dialysis monitoring, early detectionof chronic kidney disease, acute kidney disease detection and managementOxygen and Resting metabolic rate, respiratory quotient, Carbon Dioxideoxygen uptake Isoprene Lung injury, cholesterol synthesis, smokingdamage Pentane Lipid peroxidation (breast cancer, transplant rejection),oxidative tissue damage, asthma, smoking damage, chronic obstructivepulmonary disease (″COPD″) Candidate Analyte IllustrativePathophysiology/Physical State Ethane Smoking damage, lipidperoxidation, asthma, COPD Alkanes Lung disease, cancer metabolicmarkers Benzene Cancer metabolic monitors Carbon-13 H. pylori infectionMethanol Ingestion, bacterial flora Leukotrienes Present in breathcondensate, cancer markers Hydrogen peroxide Present in breathcondensate Isoprostane Present in breath condensate, cancer markersPeroxynitrite Present in breath condensate Cytokines Present in breathcondensate Glycans Glucose measurement, metabolic anomalies (e.g.,collected from cellular debris) Carbon monoxide Inflammation in airway(asthma, bronchiectasis), lung disease Chloroform DichlorobenzeneCompromised pulmonary function Trimethyl amine Uremia Dimethyl amineUremia Diethyl amine Intestinal bacteria Methanethiol Intestinalbacteria Methylethylketone Lipid metabolism O-toluidine Cancer markerPentane sulfides Lipid peroxidation Hydrogen sulfide Dental disease,ovulation Sulfated Cirrhosis hydrocarbon Cannabis Drug concentrationG-HBA Drug testing Nitric oxide Inflammation, lung disease PropaneProtein oxidation, lung disease Butane Protein oxidation, lung diseaseOther Ketones Lipid metabolism (other than acetone) Candidate AnalyteIllustrative Pathophysiology/Physical State Ethyl mercaptane CirrhosisDimethyl sulfide Cirrhosis Dimethyl disulfide Cirrhosis Carbon disulfideSchizophrenia 3-heptanone Propionic acidaemia 7-methyl tridecane Lungcancer Nonane Breast cancer 5-methyl tridecane Breast cancer 3-methylundecane Breast cancer 6-methyl Breast cancer pentadecane 3-methylpropanone Breast cancer 3-methyl Breast cancer nonadecane 4-methyldodecane Breast cancer 2-methyl octane Breast cancer Trichloroethane2-butanone Ethyl benzene Xylene (M, P, O) Styrene TetrachloroetheneToluene Ethylene Hydrogen

The inherent relative advantage of breath analysis over othertechniques, together with the relatively wide array of analytes andanalyte correlations, illustrate that the potential benefits breathanalysis offers are substantial.

Notwithstanding these potential benefits, however, with the exception ofbreath ethanol devices used for law enforcement, there has been apaucity of breath analyzers on the commercial market, particularly inmedically-related applications. This lack of commercialization isattributable in large measure to the relatively substantial technicaland practical challenges associated with the technology. Principal amongthem is the requirement for sensitivity. Analytes of interest,particularly endogenous analytes, often are present in extremely lowconcentrations, e.g., of only parts per million (“ppm”) or parts perbillion (“ppb”). In addition, the requirements for discrimination orselectivity is of critical concern. As noted herein above, breathtypically includes a large number, sometimes hundreds, of chemicalcomponents in a complex matrix. Breath also usually has considerablemoisture content. Chemical sensing regimes conducive for breath ammoniameasurement, for example, are preferably sensitive to 50 ppb in thepresence of 3 to 6% water vapor with 3 to 5% carbon dioxide.Successfully and reliably sensing a particular analyte in such aheterogeneous and chemically-reactive environment presents substantialchallenges.

Most publicly-known breath analysis devices and methods involve using asingle breath, and more specifically a single exhalation, as the breathsample to identify or measure a single analyte. The sample is collectedand analyzed to determine whether the analyte is present, and in somecases, to measure its concentration. The breath analysis systemintroduced by Abbott Laboratories, e.g., in U.S. Pat. Nos. 4,970,172,5,071,769, and 5,174,959, provides an illustrative example. There,Abbott used a single exhalation from a patient to detect the presence ofacetone to obtain information about fat metabolism.

Notwithstanding the potential benefits of breath analysis, particularlyportable breath analysis devices for home or field use, commercialofferings of such devices have been available only recently, and theaccuracy and reliability in such settings have left much room forimprovement. Practical breath analysis devices must operate accuratelyand reliably in the context of their use, e.g., in patient homes,clinics, etc., in varying environments, (temperatures, humidity, etc.),with various types of patients, over the life of the devices.

The use of multiple breaths is substantially lesser known and studied.Published reports generally have been limited to the determination ofthe production rate of carbon dioxide and the consumption rate ofoxygen. This technique was developed due to the presence of these twoanalytes (oxygen and carbon dioxide) in the ambient atmosphere.

These approaches have been limited and relatively deficient, however,for example, in that the breath sample or samples are collected in bulk,so that the analyte of interest is mixed in with other constituents.This often dilutes the analyte and increases the difficulty ofdiscriminating the desired analyte. These approaches also limit theflexibility of the breath analysis to undertake more specialized orcomplex analyses.

Additionally, such approaches are relatively deficient because theinstrumentation used for single breath analysis usually is differentfrom and sometimes inadequate for multiple breath analyte measurement.

Yet another challenge to breath analysis involves the fluid mechanicalproperties of the breath sample as it travels through the measurementdevice.

There is considerable advantage in providing breath analysis devicesthat can accurately and reliably sense or measure breath analytes in aclinical or patient home setting. Thus, there is a need for small orportable, cost effective devices and components.

In many instances, there is a need or it is desirable to make theanalysis for an analyte in the field, or otherwise to make suchassessment without a requirement for expensive and cumbersome supportequipment such as would be available in a hospital, laboratory or testfacility. It is often desirable to do so in some cases with a largelyself-contained device, preferably portable, and often preferably easy touse. It also is necessary or desirable in some instances to have thecapability to sense the analyte in the fluid stream in real time or nearreal time. In addition, and as a general matter, it is highly desirableto accomplish such sensing accurately and reliably.

The background matrix of breath presents numerous challenges to sensingsystems, which necessitate complex processing steps and which furtherpreclude system integration into a form factor suitable for portableusage by layman end-users. For example, breath contains high levels ofhumidity and moisture, which may interfere with the sensor or causecondensation within the portable device, amongst other concerns. Also,the flow rate or pressure of breath as it is collected from a usertypically varies quite considerably. Flow rate variations are known toimpact, often significantly, the response of chemical sensors. Breath,especially when directly collected from a user, is typically at or nearcore body temperature, which may be considerably different than theambient temperature. Additionally, body temperature may vary from userto user or from day to day, even for a single user. Devising a breathanalyzer thus is a non-trivial task, made all the more difficult toextent one tries to design a portable and field-amenable device.

Notably, the measurement of endogenous analytes in breath presentsdifferent challenges and requires different techniques and devices thanthe measurement of exogenous analytes. Endogenous analytes are thosethat are produced by the body, excluding the lumen of thegastrointestinal tract, whereas exogenous analytes are those that arepresent in breath as a result of the outside influence or as a result ofuser consumption. However, many analytes are produced endogenously andcan also be exogenously introduced. For example, ammonia is producedendogenously through the metabolism of amino acids, but can also beintroduced exogenously from the environment such as ammonia-containinghousehold cleaning supplies. The term “endogenous” is used according toits common meaning within the field. Endogenous analytes are produced bynatural or unnatural means within the human body, its tissues or organs,typically excluding the lumen of the gastrointestinal tract.

There are a number of significant challenges to measuring endogenousanalytes in breath. Endogenous analytes typically have significantlylower concentrations in the breath, often on the order of parts permillion (“ppm”), parts per billion (“ppb”), or less. Additionally,measurement of endogenous analytes requires discrimination of theanalyte in a complex matrix of background gases. Instead of typicalatmospheric gas composition (e.g., primarily nitrogen), exhaled breathhas high humidity content and larger carbon dioxide concentration. Thisleads to unique challenges in chemical sensitivity, selectivity andstability. For example, chemistries conducive for breath ammoniameasurement are preferably sensitive to 50 ppb in the presence of 3 to6% water vapor with 3 to 5% carbon dioxide.

Because of the historical difficulty in even detecting endogenous breathanalytes, other challenges have not been extensively investigated.Examples of such challenges include: (a) correlating the analytes tohealth or disease states, (b) measuring these analytes givencharacteristics of human exhalation, e.g., flow rate and expiratorypressure, (c) measuring these analytes sensitively and selectively, and(d) doing all these in a portable, cost effective package that can beimplemented in medical or home settings.

Colorimetric devices are one method for measuring a reaction involving abreath analyte. Colorimetric approaches to endogenous breath analysishave historically been plagued with lengthy response times, andexpensive components. Often such analysis has to be performed in alaboratory.

Breath analysis has also been performed with systems that use collectionbags (such as gas chromatography) or systems that involve little to noflow restriction on the part of the user (such as capnography systems oralcohol breath analyzers). These solutions, however, do not address theproblem of measuring low concentrations of volatile organic compounds(VOCs), such as acetone, or other analytes at ppm levels in a home orpoint of care environment for at least two reasons. First, using a bagis not desirable for a device that is primarily used at home, especiallyas sustainability becomes more of a design priority and given theobvious human factors implications. Second, systems that measure lowconcentrations of VOCs or other analytes typically involve biosensors orcapture mechanisms that have a non-trivial level of flow resistance. Forusers who may have restrictions around facial muscles, making a completeseal with a breath analysis device to provide a breath sample withoutlosing the valuable sample due to air leak between the user and devicemay be a challenge.

Thus, there remains a need for a breath analyzer that can measureendogenous breath components present in relatively low concentrations,such as acetone, accurately and quickly, without a long wait period forresults, in addition to being inexpensive and useable by the layperson.There also remains a need for an improved interface to seal between auser and a breath analysis device to minimize or prevent air leaksduring the collection of a breath sample. It is also preferable if thebreath analyzer is capable of measuring multiple analytes.

The above-noted problems are not necessarily addressed by all of thedisclosed embodiments. For example, some problems may be addressed bysome embodiments, while other problems are addressed by otherembodiments. Thus, the foregoing description should not be relied uponto limit the scope of protection.

SUMMARY

The embodiments disclosed herein each have several aspects no single oneof which is solely responsible for the disclosure's desirableattributes. Without limiting the scope of this disclosure, its moreprominent features will now be briefly discussed. After considering thisdiscussion, and particularly after reading the section entitled“Detailed Description,” one will understand how the features of theembodiments described herein provide advantages over existing systems,devices and methods for breath analysis.

Disclosed herein is a breath sample analysis cartridge, including anouter body, one or more vents, a window, a porous structure, areservoir, a piston, and a desiccant. The outer body has a proximal end,a distal end and a longitudinal axis extending between the proximal endand the distal end. The one or more vents and the window are at thedistal end of the outer body. The porous structure is proximal to thewindow and supports an interactant. The reservoir contains a developersolution and is proximal to the porous structure and separated from theporous structure by a gap. The piston is proximal to the reservoir andis moveable along the longitudinal axis to move the reservoir intocontact with the porous structure and cause the developer solution topass through the porous structure and come into contact with theinteractant. The desiccant is carried by the piston. The cartridge isconfigured to cause a breath sample that enters the proximal end of theouter body to be routed into the proximal end of the outer body, atleast partially through the desiccant carried by the piston to remove atleast some moisture from the breath sample, through the porousstructure, through the interactant, and out the one or more vents at thedistal end of the outer body. The interactant captures an analyte ofinterest from the breath sample. The developer solution, when in contactwith the interactant, initiates a reaction that causes a color change.

In the above breath sample analysis cartridge or in other embodiments asdescribed herein, one or more of the following features may also beprovided. In some embodiments, the cartridge is in combination with abreath analysis device configured to receive the cartridge, the breathanalysis device comprising a mouthpiece and configured to route thebreath sample exhaled into the mouthpiece through the cartridge, thebreath analysis device further comprising an optical sensor configuredto measure said color change. In some embodiments, the outer body issubstantially cylindrical and has a length between 0.25″ and 1.5″. Insome embodiments, the reservoir comprises a fibrous, compressible,and/or sponge-like material. In some embodiments, the desiccantcomprises a fibrous and/or absorbent material.

Disclosed herein is a breath sample analysis cartridge, including anouter body, a window, a porous structure, a reservoir, a piston, and adesiccant. The outer body has a proximal end, a distal end and alongitudinal axis extending between the proximal end and the distal end.The window is at the distal end of the outer body. The porous structureis proximal to the window and supports an interactant. The reservoircontains a developer solution and is proximal to the porous structureand separated from the porous structure by a gap. The piston is proximalto the reservoir and is moveable along the longitudinal axis to move thereservoir into contact with the porous structure and cause the developersolution to pass through the porous structure and come into contact withthe interactant. The desiccant is carried by the piston.

In the above breath sample analysis cartridge or in other embodiments asdescribed herein, one or more of the following features may also beprovided. In some embodiments, the outer body is substantiallycylindrical and has a length between 0.25″ and 1.5″. In someembodiments, the cartridge further comprises one or more channelsextending from the proximal end of the outer body and along an innerwall of the outer body to allow passage of a breath sample to the porousstructure. In some embodiments, the one or more channels comprises aplurality of channels separated by a plurality of ribs extendingradially inwardly from the inner wall of the outer body. In someembodiments, the plurality of ribs comprise one or more features toretain the piston in a proximal position within the cartridge. In someembodiments, the plurality of ribs comprise one or more features toretain the piston in a distal position within the cartridge. In someembodiments, the piston moves the reservoir into contact with the porousstructure and causes the developer solution to pass through the porousstructure and come into contact with the interactant when moved into thedistal position. In some embodiments, the piston is moved into thedistal position by a distal force applied to a proximal protrusion ofthe piston. In some embodiments, the outer body comprises one or morevents at the distal end. In some embodiments, the interactant comprisessilica beads. In some embodiments, the reservoir comprises a fibrous,compressible, and/or sponge-like material. In some embodiments, thedesiccant comprises a fibrous and/or absorbent material. In someembodiments, the desiccant is configured to absorb moisture from abreath sample passed through the cartridge. In some embodiments, thedesiccant is configured to absorb moisture from a packaging environmentof the cartridge. In some embodiments, the desiccant carried by thepiston surrounds a shaft of the piston. In some embodiments, thedesiccant carried by the piston is contained within a cage or a basketof the piston. In some embodiments, the porous structure comprises aporous bowl. In some embodiments, the reservoir is carried by a distalend of the piston. In some embodiments, the reservoir is separated froma distal end of the piston by a gap. In some embodiments, the cartridgeis in combination with a breath analysis device configured to receivethe cartridge, the breath analysis device comprising a mouthpiece andconfigured to route a breath sample exhaled into the mouthpiece throughthe cartridge, the breath analysis device further comprising an opticalsensor configured to measure a color change in the cartridge.

Disclosed herein is a breath sample analysis cartridge, including anouter body, a porous structure, a reservoir, a piston, and a desiccant.The outer body has a proximal end, a distal end and a longitudinal axisextending between the proximal end and the distal end. The porousstructure is adjacent the distal end of the outer body and supports aninteractant. The reservoir is proximal to the porous structure andcontains a developer solution. The piston is proximal to the reservoirand is moveable along the longitudinal axis to cause the developersolution to come into contact with the interactant. The desiccant iscarried by the piston.

In the above breath sample analysis cartridge or in other embodiments asdescribed herein, one or more of the following features may also beprovided. In some embodiments, the cartridge further comprises anintermediate layer disposed between the porous structure and thereservoir, the intermediate layer configured to receive the developersolution from the reservoir and transmit the developer solution to theinteractant upon distal movement of the piston along the longitudinalaxis. In some embodiments, the intermediate layer comprises a porousmaterial. In some embodiments, the cartridge further comprises one ormore channels extending from the proximal end of the outer body andalong an inner wall of the outer body to allow passage of a breathsample to the porous structure. In some embodiments, an inner wall ofthe outer body comprises one or more features to retain the piston in aproximal position within the cartridge. In some embodiments, an innerwall of the outer body comprises one or more features to retain thepiston in a distal position within the cartridge. In some embodiments,the outer body comprises one or more vents and a window at the distalend. In some embodiments, the interactant comprises silica beads. Insome embodiments, the reservoir comprises a fibrous, compressible,and/or sponge-like material. In some embodiments, the desiccantcomprises a fibrous and/or absorbent material. In some embodiments, thedesiccant is configured to absorb moisture from a breath sample passedthrough the cartridge. In some embodiments, the desiccant is configuredto absorb moisture from a packaging environment of the cartridge. Insome embodiments the desiccant carried by the piston surrounds a shaftof the piston. In some embodiments, the desiccant carried by the pistonis contained within a cage or a basket of the piston. In someembodiments, the cartridge is in combination with a breath analysisdevice configured to receive the cartridge, the breath analysis devicecomprising a mouthpiece and configured to route a breath sample exhaledinto the mouthpiece through the cartridge, the breath analysis devicefurther comprising an optical sensor configured to measure a colorchange in the cartridge.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1F show various views of an embodiment of a breath samplecapture cartridge. FIG. 1A shows a distal end perspective view of anembodiment of a breath sample capture cartridge. FIG. 1B shows aproximal end perspective view of the breath sample capture cartridge ofFIG. 1A. FIG. 1C shows a distal end view of the breath sample cartridgeof FIG. 1A. FIG. 1D shows a proximal end view of the breath samplecartridge of FIG. 1A. FIG. 1E shows a side view of the breath samplecartridge of FIG. 1A. FIG. IF shows a cross-sectional side view of thebreath sample capture cartridge of FIG. 1A.

FIGS. 2A-2B show exploded views of an embodiment of a breath samplecapture cartridge.

FIGS. 3A-3H show various views of an embodiment of a canister of abreath sample capture cartridge. FIGS. 3A-3B show distal end perspectiveviews of an embodiment of a canister of a breath sample capturecartridge. FIGS. 3C-3D show proximal end perspective views of thecanister of FIGS. 3A-3B. FIG. 3E shows a distal end view of the canisterof FIGS. 3A-3B. FIG. 3F shows a proximal end view of the canister ofFIGS. 3A-3B. FIG. 3G shows a side view of the canister of FIGS. 3A-3B.FIG. 3H shows a cross-sectional side view of the canister of FIGS.3A-3B.

FIGS. 4A-4B show proximal end and distal end perspective views of anembodiment of a desiccant and a reservoir in relation to a piston of abreath sample capture cartridge.

FIGS. 5A-5B show cross-sectional views of an embodiment of a breathsample capture cartridge with a piston at two positions along alongitudinal axis of the breath sample capture cartridge with adesiccant and a reservoir removed from view.

FIGS. 6A-6B show schematic views of an embodiment of a piston causing adeveloper solution of a reservoir to pass through a porous structuresupporting an interactant and come into contact with the interactant.

FIGS. 7A-7B show various views of an embodiment of a breath analysisdevice with a breath sample cartridge removed from the breath analysisdevice. FIG. 7A shows a proximal end top perspective view and FIG. 7Bshows a distal end top perspective view.

FIGS. 8A-8B show various views of an embodiment of a breath analysisdevice with a breath sample cartridge installed in the breath analysisdevice. FIG. 8A shows a proximal end top perspective view and FIG. 8Bshows a distal end top perspective view.

FIGS. 9A-9G show various views of an embodiment of a breath analysisdevice. FIG. 9A shows a top view of an embodiment of a breath analysisdevice. FIG. 9B shows a side view of the breath analysis device of FIG.9A. FIG. 9C shows a proximal end view of the breath analysis device ofFIG. 9A. FIG. 9D shows a distal end view of the breath analysis deviceof FIG. 9A. FIG. 9E shows a cross-sectional side view of the breathanalysis device of FIG. 9A without a breath sample capture cartridgeinstalled. FIG. 9F shows a cross-sectional side view of the breathanalysis device of FIG. 9A with a breath sample capture cartridgeinstalled. FIG. 9G shows a proximal end cross-sectional perspective viewof the breath analysis device of FIG. 9A without a breath sample capturecartridge installed.

FIGS. 10A-10J show various views of an embodiment of a mouthpiece of abreath analysis device. FIG. 10A shows a proximal end top perspectiveview of an embodiment of a mouthpiece of a breath analysis device. FIG.10B shows a proximal end bottom perspective view of the mouthpiece ofFIG. 10A. FIG. 10C shows a distal end top perspective view of themouthpiece of FIG. 10A. FIG. 10D shows a distal end bottom perspectiveview of the mouthpiece of FIG. 10A. FIG. 10E shows a top view of themouthpiece of a FIG. 10A. FIG. 1OF shows a bottom view of the mouthpieceof FIG. 10A. FIG. 10G shows a proximal end view of the mouthpiece ofFIG. 10A. FIG. 10H shows a distal end view of the mouthpiece of FIG.10A. FIG. 10I shows a side view of the mouthpiece of FIG. 10A. FIG. 10Jshows a cross-sectional side view of the mouthpiece of FIG. 10A.

FIGS. 11A-11C show various views of a variant of the breath samplecapture cartridge of FIGS. 1A-1F. FIG. 1G shows a proximal endperspective view, FIG. 1H shows a proximal end view, and FIG. 1I shows across-sectional side view of the variant of the breath sample capturecartridge.

FIGS. 12A-12B show exploded views of a variant of a breath samplecapture cartridge.

FIGS. 13A-13H show various views of a variant of a canister of a breathsample capture cartridge. FIGS. 13A-13B show distal end perspectiveviews, FIGS. 13C-13D show proximal end perspective views, FIG. 13E showsa distal end view, FIG. 13F shows a proximal end view, FIG. 13G shows aside view, and FIG. 13H shows a cross-sectional side view of the variantof the canister.

FIGS. 14A-14B show proximal end and distal end perspective views of avariant of a piston in relation to a reservoir of a breath samplecapture cartridge.

FIG. 14C shows a distal end perspective exploded view of the variant ofthe piston of FIGS. 14A-14B in relation to a desiccant.

FIGS. 15A-15B show cross-sectional views of a variant of a breath samplecapture cartridge with a piston at two positions along a longitudinalaxis of the breath sample capture cartridge with a desiccant and areservoir removed from view.

DETAILED DESCRIPTION

Embodiments of the present disclosure are directed to breath analysissystems and devices, including breath analysis devices as described withrespect to FIGS. 7A-10J and breath sample capture cartridges (which canalso be referred to herein as “breath sample analysis cartridges”) asdescribed with respect to FIGS. 1A-6B and FIGS. 11A-15B. Embodiments ofthe present disclosure are also directed to breath analysis devices inwhich there is a non-trivial amount of flow resistance in the flow path,such as due to the presence of a breath sample capture cartridge,including breath analysis devices as described with respect to FIGS.7A-10J and breath sample capture cartridges as described with respect toFIGS. 1A-6B and FIGS. 11A-15B. Embodiments of the present disclosure arealso directed to breath analysis devices and components that allow for asubstantially leak-free seal between a user and the components of thebreath analysis device, such as a mouthpiece of the breath analysisdevice, that require no to little activation of the user's fascialmuscles to form the seal, including the breath analysis devices andcomponents as described with respect to FIGS. 7A-10J. Embodiments of thepresent disclosure also encompass methods for collecting a breathsample, including the use of breath analysis devices as described withrespect to FIGS. 7A-10J and breath sample capture cartridges asdescribed with respect to FIGS. 1A-6B and FIGS. 11A-15B. Further detailsregarding breath analysis devices, breath sample capture cartridges andassociated devices and methods that may be utilized with the embodimentsof the present disclosure are described in U.S. Pat. Nos. 10,591,460 and10,782,284, the entireties of both of which are hereby incorporated byreference and should be considered a part of this specification. Furtherdetails regarding sensors and sensor systems that may be utilized withthe embodiments of the present disclosure are described in U.S. Pat.Nos. 9,689,864, 9,636,044, 9,643,186, 6,609,068, and 7,364,551, theentireties of which are hereby incorporated by reference and should beconsidered a part of this specification.

Breath Sample Capture Cartridge

FIGS. 1A-1F illustrate various views of an embodiment of a breath samplecapture cartridge (which can also be referred to herein as a “breathsample analysis cartridge”) 100 that may be used to collect a fluidsample, e.g., to collect a fluid sample according to any of the numberof methods disclosed herein and utilizing any of the breath analysissystems and devices described herein. The breath sample capturecartridge 100, as shown in FIGS. 1A-1F, has an outer body with a distalend 101, a proximal end 102, and a longitudinal axis 103 extendingbetween the distal end 101 and the proximal end 102. As shown in thedistal end perspective view of FIG. 1A, cartridge 100 may include a lenscap 110 with a lens cap cover 111 and a lens cap body 113 attachedproximally to the lens cap cover 111. The lens cap 110 may include alens (which can also be referred to herein as a “window”) 112 and aplurality of lens cap vents 114. The lens cap 110 may attach distally toa canister 140, e.g., fits securely on the canister 140. Canister 140may be wrapped with a decal 105. As shown in the proximal endperspective view of FIG. 1B, cartridge 100 may also include a piston 160disposed along the canister's longitudinal axis 103. Further shown, thecanister 140 may include an inner wall 141 with a plurality of radiallyinwardly facing ribs 145 defining a plurality of channels 142 for thepassage of a breath sample. While the outer body illustrated isconstructed of the lens cap 110 and a separate canister 140, otherembodiments may construct the outer body from a unitary structure, orfrom more than two separate structures. Moreover, while the canister 140is described below as including a desiccant, other embodiments may omitthe desiccant.

The breath sample capture cartridge 100 may have an outer body diameterof between about 0.25″-0.75″, between about 0.275″-0.725″, between about0.3″-0.7″, between about 0.325″-0.675″, between about 0.35″-0.65″,between about 0.40″-0.625″, between about 0.425″ -0.60″, between about0.45″-0.575″, between ab out 0.475″-0.55″, between about 0.475″-0.525″,of about 0.50″, or any other diameter that advantageously facilitatesuse and collection of samples as disclosed herein. The breath samplecapture cartridge 100 may have a combined height, including at leastboth the lens cap 110 and the canister 140, of between about0.25″-1.50″, between about 0.275″-1.25″, between about 0.30″-1.00″,between about 0.325″-0.75″, between about 0.35″-0.5″, between about0.275″-1.25″, between about 0.30″-1.25″, between about 0.325-1.25″,between about 0.350″-1.25″, between about 0.4″-1.25″, between about0.5″-1.25″, between about 0.6″-1.25″, between about 0.7″-1.25″, betweenabout 0.8″-1.25″ between about 0.825″-1.225″ between about 0.85″-1.20″,between about 0.875″ -1.175″, between about 0.9″-1.15″, between about0.925″-1.1″, between about 0.95″-1.05″, 0.975″-1.025″, of about 1″, orany other combined height that facilitates use and collection of samplesas disclosed herein.

FIG. 1C illustrates a distal end view of the breath sample capturecartridge 100 of FIGS. 1A-1B, showing the lens cap 110 surrounded byseveral, e.g., eight, lens cap vents 114. FIG. 1D illustrates a proximalend view of the breath sample capture cartridge 100 of FIGS. 1A-1B,showing the piston 160 disposed inside the canister 140. FIG. 1Dadditionally shows several, e.g., eight, channels 142 extending betweenthe inner surface 141 of the canister 140, the ribs 145 of the canister140, and an exterior of a desiccant 150 disposed around a portion of thepiston 160.

FIG. 1E illustrates a side view and FIG. 1F illustrates across-sectional side view of an embodiment of a breath sample cartridge100 according to FIGS. 1A-1D. As shown in FIG. 1F, the outer body of thebreath sample capture cartridge may generally include, from its distalend 101 to its proximal end 102, a lens cap 110, which as shown includesa lens cap cover 111 attached to a lens cap body 113, and a canister 140attached to the lens cap 110 (as shown, attached to the lens cap body113 of the lens cap 110). Internally, the breath sample capturecartridge 100 may generally include, from its distal end 101 to itsproximal end 102, an interactant 120 supported by a porous structure 130disposed inside the lens cap 110 proximal to the lens 112, a gap 180between the porous structure 130 and a reservoir 170, the reservoir 170containing a developer solution and disposed at the distal end of thepiston 160, and the piston 160. In some embodiments, the breath samplecartridge 100 may additionally include a desiccant 150 carried by and/ordisposed around the piston 160 proximal to the reservoir 170. In someembodiments, although not shown, the breath sample capture cartridge 100can include an intermediate layer disposed between the porous structure130 and the reservoir 170 (e.g., disposed within the gap 180). Theinternal components of the breath sample capture cartridge may bedisposed inside the lens cap 110 and the inner wall 141 and ribs 145 ofthe desiccant cartridge 145.

FIGS. 2A-2B illustrate exploded views of an embodiment of a breathsample capture cartridge 100, e.g., the breath sample capture cartridge100 of FIGS. 1A-1F. The breath sample capture cartridge 100 of FIGS.2A-2B may include a lens cap 110 including a lens cap cover 111 and alens cap body 113, a porous structure 130, a reservoir 170, a canister140, a piston 160, a decal 105, and a desiccant 150.

Additional detail regarding the various components of the breath samplecapture cartridge 100 and interactions between them will now bediscussed, in particular with reference to FIG. 1F.

The lens cap 110 may be shaped generally like a cylinder and include alens 112 and at least one lens cap vent 114. In some embodiments, thelens cap 110 may have shapes other than a cylinder. For example, thelens cap 110 may have four sides, five sides, six sides, seven sideseight sides, or any other number of sides. Circular lens caps 110 mayadvantageously simplify the manufacturing process, but one of ordinaryskill in the art will easily understand that a lens cap 110 having othernumbers of sides may be used. The lens cap 110 may have a diameter ofbetween about 0.25″-0.75″, between about 0.275″-0.725″, between about0.3″-0.7″, between about 0.325″-0.675″, between about 0.35″-0.65″,between about 0.40″-0.625″, between about 0.425″-0.60″, between about0.45″-0.575″, between about between about 0.475″-0.525″, of about 0.50″,or any other diameter that advantageously facilitates use and collectionof samples as disclosed herein. The lens cap 110 may have a height ofbetween about 0.10″-0.5″, between about 0.15″-0.45″, between about0.20″-0.40″, between about 0.25″-0.40″, between about 0.30″-0.40″,between about 0.325″-0.40″, between about 0.34″-0.38″, between about0.348″-0.372″, or any other height that advantageously facilitates useand collection of samples as disclosed herein.

The lens cap 110 may be a one-piece design, or it may be a two-piecedesign as shown in FIGS. 1A-1F and 2A-2B and include a lens cap cover111 and a lens cap body 113. The lens cap cover 111 may have anengagement portion that couples the lens cap cover 111 to the lens capbody 113. As shown in FIG. 1F, the engagement portion may comprise afoot 117 on the lens cap cover 111 and an undercut 118 on the lens capbody 113, in the wall, e.g., the inner lateral wall, of the lens capbody 113. Other different types of engagement or coupling portions maybe used, including, but not limited to, threads, friction fit, etc.

In some embodiments, the engagement portion of the lens cap 110 includesfoot 117 extending proximally from the lens cap cover 111 and extendingaround the lens cap cover 111. In some embodiments, the foot 117 extendssubstantially the entire way around the lens cap cover 111, e.g., adistance of about 360°. In some embodiments, the foot 117 extends aroundthe lens cap cover 111 less than about 360°. In some embodiments, thefoot 117 comprises a plurality of distinct feet, e.g., multiple downwardprotrusions, rather than a single ring. In some embodiments, the foot117 comprises a number of feet 117 between about 3-18, between about4-16, between about 5-14, between about 6-12, and between about 7-10.

In some embodiments, the lens cap cover 111 comprises a lens cap covermating surface 116 surrounding the foot 117. The lens cap cover matingsurface 116 may be a substantially level or flat surface configured tomate with, e.g., closely mate with, a corresponding surface on the lenscap body 113.

In some embodiments, the undercut 118 of the lens cap body 113 is amirror image or negative of the foot 117 of the lens cap cover 111. Inthis way, the foot 117 may “snap” into the undercut 118 of the lens capbody 113. In embodiments in which the lens cap cover 111 has more thanone foot 117, the undercut 118 of the lens cap body 113 may includeprotrusions in the undercut 118 to index the lens cap cover 111 withrespect to the lens cap body 113. In this way, exacting alignment of thelens cap cover 111 with respect to the lens cap body 113 may bereproducibly achieved.

In some embodiments, the lens cap body 113 comprises a lens cap bodymating surface 119 on its distal surface. The lens cap body matingsurface 119 may be a substantially level or flat surface configured tomate with, e.g., closely mate with, a corresponding surface on the lenscap cover 111. For example, the lens cap body mating surface 119 of thelens cap body 113 may be configured to mate with the lens cap covermating surface 116 of the lens cap cover 111. In some embodiments, thelens cap body mating surface 119 may be configured to substantiallysealingly mate with the lens cap cover mating surface 116 of the lenscap cover 111 when the lens cap cover 111 and the lens cap body 113 areengaged (e.g., when the foot 117 engages the undercut 118).

In some embodiments, the lens cap body 113 includes a shelf 115extending radially inward below the undercut 118. The shelf 115 mayserve as a surface against which the foot 117 of the lens cap cover 111may abut when fully in place in the undercut 118. In some embodiments,the shelf 115 extends radially inward past the innermost surface of thefoot 117. In this way, the shelf 115 may also support a porous structure130, holding the porous structure 130 in the lens cap 110 between thelens cap cover 111 and the lens cap body 113.

FIG. 1F shows a lens cap cover 111 engaged with a lens cap body 113,such that the foot 117 has fully engaged the undercut 118 and isabutting the shelf 115. FIG. 1F additionally shows an assembled lens cap110, including lens cap cover 111, lens cap body 113, and porousstructure 130 held between the two. As can be seen, the shelf 115 of thelens cap body 113 supports the porous structure 130 and holds itsecurely within the lens cap cover 111.

A two-piece lens cap 110 may facilitate manufacture. In someembodiments, the lens cap 110 is manufactured by first placing aquantity of interactant 120 in a porous structure 130, which is placedon a stable and/or flat surface. A lens cap cover 111 is then placed infriction fit over the porous structure 130. As can be seen in FIG. 1F,when the porous structure 130 is fully in place within the lens capcover 111, the proximal end of the porous structure 130 and the base ofthe foot 117 are substantially aligned. Therefore, the lens cap cover111 can be installed over the porous structure 130 with some forcewithout risking damage to the porous structure 130. The lens cap cover111 may hold the porous structure 130 by friction, e.g., the innerlateral walls of the lens cap cover 111 may engage the outer lateralwalls of the porous structure 130 such that the porous structure 130will not easily slide out of the lens cap cover 111 once installed.After the porous structure 130 is installed in the lens cap cover 111,the lens cap cover 111 and the lens cap body 113 may be engaged. As theporous structure 130 is securely engaged with the lens cap cover 111,the construct of the lens cap cover 111 and the porous structure 130 maybe introduced to the lens cap body 113 distal-side-up (as shown in FIG.1F) or distal-side-down. The construct of the porous structure 130 andthe lens cap cover 111 may simply be snapped into place within the lenscap body 113 to complete the two-piece lens cap 110.

In embodiments with a one-piece lens cap 110, the lens cap 110 may beconfigured to accept and hold the porous structure 130. To hold theporous structure 130, the lens cap 110 may have a retention or holdingfeature on its inner wall. In some embodiments, the lens cap 110 mayhave a continuous or partial ledge or step on its inner wall. Forexample, the lens cap 110 may have a continuous ramped step (e.g.,ramped from the proximal end, and flat on the distal end) that is spaceda distance from the inner surface of the distal end of the lens cap 110substantially equal to the height of the porous structure 130. Such acontinuous ramped step may have a maximum width of about 0.13 mm. Inother embodiments, a continuous ramped step may have a maximum width inthe range of about 0.05-0.5 mm. In some embodiments, the retention orholding feature may not extend around the entirety of the lens cap 110.In some embodiments, the retention or holding feature may comprise oneor more undercuts. The undercuts may be present with or without acontinuous or discontinuous ramped step. The undercut may be a partialconical surface with a flat upper surface facing the distal end of thelens cap 110. Undercuts may augment or replace a continuous or partialsmaller retention or holding feature. In some embodiments, the lens cap110 has no retention or holding feature and retains the porous structure130 through friction. In other embodiments, the porous structure 130 isheld within the lens cap 110 by a distal surface of the canister 140pushing up against the bottom of the porous structure 130 which holdsthe distal surface of the porous structure 130 against the inner surfaceof the distal end of the lens cap 110.

As shown in FIGS. 1A, 1C, and 1F, the distal end of the lens cap 110 mayinclude a lens 112. The lens 112 may be approximately in the center ofthe distal end of the lens cap 110. As is discussed herein, the lens 112may be used in an optical analysis of a sample (e.g., a photosensormeasures a change in light reflectance of an interactant held behind thelens 112). For example, various embodiments of a breath analysis devicedescribed later herein may use photosensors or optical sensors to senseor detect one or more optical characteristics through the lens 112(e.g., an optical characteristic of the interactant 120). As such, insome embodiments, the lens 112 may have a high degree of transparency.As used herein, transparency is the amount of light that passes througha barrier (e.g., the lens 112)—that is to say the total amount of lightsubtracting the amount of light reflected by the barrier and subtractingthe amount of light absorbed by the barrier.

In some embodiments, the lens 112 has a transparency to the wavelengthof light being measured (e.g., some materials have differenttransparencies to different wavelengths of light) of at least about 60%,at least about 65% at least about 70% at least about 75%, at least about80%, at least about 82.5%, at least about 85%, at least about 86%, atleast about 87%, at least about 88%, at least about 89%, at least about90%, at least about 92%, at least about 93%, at least about 94%, atleast about 95%, at least about 96%, at least about 97%, at least about98%, at least about 99%, or any of amount of transmittance thatadvantageously facilitates analysis of a sample through the lens 112 asdisclosed herein. Of course, a lens 112 having a transmission of lessthan about 60% may be used; however, one of ordinary skill in the artwill understand that other parameters of the system may need to beadjusted to compensate for the losses due to reflectance and absorbanceby the lens 112.

As shown in FIGS. 1A and 1C, the lens 112 may be circular. The lens 112may have other shapes. For example, the lens 112 may have the samenumber of sides as the lens cap 110 of which it is a part (e.g., afour-sided lens cap 110 may have a four-sided lens 112, and aneight-sided lens cap 110 may have an eight-sided lens 112). In someembodiments, the lens 112 forms the entire top of the lens cap 110(e.g., the at least one lens cap vent 114 is cut into or formed in anedge of the lens 112 that forms the top of the lens cap 110). The lens112 can be substantially flat (e.g., not concave or convex). In somecases, the lens 112 can be made of a transparent plastic.

As shown in FIG. 1F, the lens 112 has a thickness. In some embodiments,the thickness of the lens 112 is less than the depth (distal toproximal) of the lens cap vents 114: in that way, the thickness of thelens 112 and the vertical depth of the lens cap vents 114 defines thethickness of the lens cap vents 114 (e.g., the size of the lens capvents 114 may be defined by the width of each lens cap vent 114, thedepth of each lens cap vent 114 along the longitudinal axis of cartridge100, the radial depth of each lens cap vent 114, and the thickness ofthe lens 112). In some embodiments, the thickness of the lens 112 isabout 0.75 mm. In some embodiments, the thickness of the lens 112 is inthe range of between about 0.5-3 mm, between about 0.525-2.8 mm, betweenabout 0.55-2.6 mm, between about 0.575-2.4 mm, between about 0.60-2.2mm, between about 0.625-2 mm, between about 0.65-1.8 mm, between about0.675-1.6 mm, between about 0.70-1.4 mm, between about 0.725-1.2 mm, orany other thickness that advantageously facilitates airflow through thebreath sample capture cartridge 100 and/or analysis of a sample throughthe lens 112 as disclosed herein.

As best seen in FIG. 1A, in some embodiments, the lens cap vents 114 arecut radially into the top of the lens cap 110 deeper than the thicknessof an inner side wall of the lens cap 110. In some embodiments, the lenscap vents 114 are cut into or formed in only the inner sidewall of thelens cap 110 (e.g., they do not extend into the top of the lens cap110). In such embodiments, the top of the lens cap 110 may approximatelyresemble a disk set on a crenulated cylinder (e.g., in this case, thelens cap vents 114 would exit only to the side of the lens cap 110rather than also forming an exit on/from the top of the lens cap 110).In some embodiments, the entire top of the lens cap 110 is formed out ofthe lens 112. In some embodiments, the top of the lens cap 110 is asolid disc (e.g., no lens cap vent 114 is cut/formed into the top, butis rather cut/formed into the side of the lens cap 110) and the lens 112is only in the center of the top of the lens cap 110. In someembodiments, the lens cap 110 includes an outer wall side wall thatforms a ring around the lens cap vents 114. In some embodiments, eachlens cap vent 114 may be formed in a generally radial fashion (e.g., thesides of each lens cap vent 114 are not parallel), as shown in FIGS. 1Aand 1C. In some embodiments, each lens cap vent 114 is between about 15and 25 degrees wide. In other embodiments, each lens cap vent 114 isless than about 5 degrees wide, less than about 10 degrees wide, lessthan about 15 degrees wide, less than about 20 degrees wide, less thanabout 25 degrees wide, less than about 30 degrees wide, less than about40 degrees wide, less than about 50 degrees wide, less than about 60degrees wide, less than about 70 degrees wide, less than about 80degrees wide, less than about 90 degrees wide, or any other degree ofwidth that advantageously facilitates sample collection as disclosedherein. In some embodiments, each lens cap vent 114 is formed as a notchin the corner of the lens cap 110 (e.g., the sides of each lens cap vent114 are parallel, or substantially parallel).

In some embodiments each lens cap vent 114 has three sides (e.g., is atrapezoidal cut or void in the edge of the lens cap 110). In otherembodiments, each lens cap vent 114 has only two sides (e.g., is av-shaped cut or void in the edge of the lens cap 110).

In some embodiments, such as the embodiment shown in FIGS. 1A and 1C,the lens cap vents 114 are spaced evenly around the edge of the lens cap110 (e.g., about every 45 degrees). In other embodiments, the lens capvents 114 are grouped in patterns. In some embodiments, the lens capvents 114 are arranged in patterns so as to facilitate spiral outflow offluid from the interior of lens cap 110 of the breath sample capturecartridge 100. In some embodiments, the lens cap vents 114 are arrangedin patterns so as to facilitate turbulent outflow of fluid from theinterior of lens cap 110 of the breath sample capture cartridge 100.

In some embodiments, the lens cap vents 114 are formed at asubstantially right angle with respect to the lens 112. In someembodiments, the lens cap vents 114 are cut or formed obliquely in theedge of the lens cap 110 (rather than radially) to facilitate spiraloutflow of fluid from the interior of the lens cap 110 of the breathsample capture cartridge 100. In some embodiments, the lens cap vents114 are cut or formed obliquely in the edge of the lens cap 110 (ratherthan radially) to facilitate turbulent outflow of fluid from theinterior of the lens cap 110 of the breath sample capture cartridge 100.

In some embodiments, the lens cap vents 114 have a vertical depth (e.g.,from the distal end of the lens cap 110 to the proximal end of each lenscap vent 114. Along with other features of the lens cap 110, the depthof the lens cap vents 114 may define the size of the various lens capvents 114. In some embodiments, the depth of the lens cap vents 114 isabout 0.75 mm. In some embodiments, the depth of the lens cap vents 114is in the range of between about 0.5-3 mm, between about 0.525-2.8 mm,between about 0.55-2.6 mm, between about 0.575-2.4 mm, between about0.60-2.2 mm, between about 0.625-2 mm, between about 0.65-1.8 mm,between about 0.675-1.6 mm, between about 0.70-1.4 mm, between about0.725-1.2 mm, or any other depth that advantageously facilitates airflowthrough the breath sample capture cartridge 100 and/or analysis of asample through the lens 112 as disclosed herein.

One of ordinary skill in the art will understand that various featuresof the lens cap 110 may be changed. For example, certain features of thelens cap 110 that may be changed include, but are not limited to: thesize, shape, and number of the lens cap vents 114; the size, shape, andthickness of the lens 112; the diameter of the lens cap 110; and theheight of the lens cap 110. The embodiment of the lens cap 110 shown inFIGS. 1A and 1C includes eight lens cap vents 114. Other numbers ofvents may be used. In some embodiments, the lens cap 110 has at least 1vent, at least 2 vents, at least 3 vents, at least 4 vents, at least 5vents, at least 6 vents, at least 7 vents, at least 8 vents, at least 9vents, at least 10 vents, at least 11 vents, at least 12 vents, between12 and 20, or any number of vents that advantageously facilitates samplecollection as disclosed herein.

FIGS. 1F, 2A and 2B illustrate various views of an embodiment of aporous structure 130 that may be used in conjunction with the varioussystems and methods disclosed herein. In some embodiments, the porousstructure 130 may be configured in a bowl shape. However, reference tothis element as a bowl should not limit the scope of this disclosure.The porous element or member (e.g., bowl) may have any of a number ofother shapes. For example the porous structure may be a disc, a frit, amolded solid, a solid, a molded shape, a slice, etc.

The porous structure 130 may be formed to match an inner surface of alens cap 110. For example, the porous structure 130 shown in FIG. IF isconfigured to fit within a lens cap 110 having a substantially rightangle where the side-wall(s) (e.g., the cylindrical side wall) of thelens cap 110 meet the distal inner surface of the lens cap 110. Theporous structure 130 and the lens cap 110 may be configured to closelymatch (e.g., the porous structure 130 is a negative of an internalsurface of the lens cap 110) so that the porous structure 130 prevents asubstance or material (e.g., interactant 120) contained within theporous structure 130 from exiting the porous structure 130 and lens cap110 through the lens cap vents 114. In some embodiments, the porousstructure 130 may have rounded corners (e.g., a rounded externalcorner(s) matching a rounded internal corner(s) on an interior surfaceof the lens cap 110). While the porous structure 130 is described withreference to the accompanying figures, one of ordinary skill in the artwill understand that various features of the porous structure 130 may bechanged.

The porous structure 130 may have a diameter, most simply seen in FIG.1F. The diameter of the porous structure 130 may be selected to closelymatch an internal diameter of the lens cap 110. It may be desirable thatthe porous structure 130 fit snugly, tightly, immovably, or fixedlywithin the lens cap 110. The diameter of the porous structure 130 may bebetween about 7.9-8.4 mm. In other embodiments, the diameter of theporous structure 130 is between about 4-30 mm, between about 5-25 mm,between about 6-20 mm, between about 6.5-15 mm, between about 7-10 mm,between about 7.5-9 mm, or any other diameter that advantageouslyfacilitates use and collection of samples as disclosed herein.

The porous structure 130 may have a height, most simply seen in FIG. 1F.The porous structure's height may be from the proximal side of theporous structure base 134 to the distal side of the porous structurewall 132. In some embodiments, the height of the porous structure 130 isabout 1.9-2 mm. In other embodiments, the height of the porous structure130 is between about 0.5-3 mm, between about 0.55-2.9 mm, between about0.6-2.8 mm, between about 0.65-2.7 mm, between about 0.7-2.6 mm, betweenabout 0.75-2.5 mm, between about 0.8-2.4 mm, between about 0.85-2.3 mm,between about 0.9-2.2 mm, between about 0.95-2.1 mm, or any other heightthat advantageously facilitates use and collection of samples asdisclosed herein.

The porous structure 130 may have an inner depth, most simply seen inFIG. 1F. The inner depth may be from the distal side of the porousstructure base 134 to the distal side of the porous structure wall 132.In some embodiments, the inner depth is about 0.838 mm. In otherembodiments, the inner depth is in the range of between about 0.5-3 mm,between about 0.525-2.8 mm, between about 0.55-2.6 mm, between about0.575-2.4 mm, between about 0.60-2.2 mm, between about 0.625-2 mm,between about 0.65-1.8 mm, between about 0.675-1.6 mm, between about0.70-1.4 mm, between about 0.725-1.2 mm, or any other depth thatadvantageously facilitates airflow through the breath sample capturecartridge 100 and/or analysis of a sample through the lens 112 asdisclosed herein.

The porous structure 130 may have an inner diameter, most simply seen inFIG. 1F. In some embodiments, the inner diameter is about 6.35 mm. Inother embodiments, the inner diameter is in the range of between about5.0-8.0 mm, between about 5.5-7.5 mm, between about 5.75-7.25 mm,between about 6.0-7.0 mm, or any other diameter that advantageouslyfacilitates use and collection of samples as disclosed herein.

As will be explained in more detail herein, the porous structure 130 maycontain an interactant that collects and/or reacts with a sample andthat experiences a physical change that may by assessed or measuredthrough the lens 112. Thus, it is desirable that the porous structure130 permit fluid flow therethrough. One of ordinary skill in the artwill understand that the pore size of the porous structure 130 isdependent on at least two factors, including, but not limited to: 1) thenecessary fluid flow rate through the porous structure 130 (e.g.,through the breath sample capture cartridge 100) (it will be easilyunderstood that in some embodiments the porous structure 130 is theindividually greatest restriction to fluid flow through the breathsample capture cartridge 100) and 2) the particle size that must be heldby the porous structure 130 (e.g., the particle size of the interactant120 material). Stated differently, fluid flow rate through the breathsample capture cartridge 100 may be limited by the porous structure 130and, more specifically, by the pore size of the porous structure 130.Additionally, the material contained within the porous structure 130 mayhave a quite small particle size, and it may be desirable to have a poresize of the porous structure 130 that prevents all or substantially allof the material contained within the porous structure 130 from passingthrough the porous structure base 134 or porous structure wall 132 ofthe porous structure 130 (e.g., it may be desirable to avoid the porousstructure 130 acting like a sieve to the material it contains).

In some embodiments, the porous structure 130 has a pore size of about130 μm. In some embodiments, the porous structure 130 has a pore sizeless than about 250 μm. In some embodiments, the porous structure 130has a pore size in the range of between about 5-400 μm, between about10-380 μm, between about 15-360 μm, between about 20-340 μm, betweenabout 25-320 μm, between about 30-300 μm, between about 35-280 μm,between about 40-260 μm, between about 45-240 μm, between about 50-220μm, between about 55-200 μm, between about 60-180 μm, between about65-175 μm, between about 70-170 μm, between about 75-165 μm, betweenabout 80-160 μm, between about 85-155 μm, between about 90-150 μm,between about 95-145 μm, between about 100-140 μm, between about 105-135μm, between about 110-130 μm, between about 115-125 μm, or any otherpore size that both strikes an advantageous balance between retainingany particle(s) within the porous structure 130 (e.g., preventing exitof the substance intended to be held within the bowl) and allowing thedesired fluid flow rate through the porous structure 130.

In some embodiments, the porous structure 130 has dimensions and poresize that permits a flow rate through the porous structure 130 ofbetween about 300-750 ml/min (e.g., the flow rate may be due to or underthe pressure of a user blowing into a device holding the breath samplecapture cartridge and directing the breath into and through thecartridge). In some embodiments, the porous structure 130 may permit aflow rate through the porous structure 130 of between about 4000-9000ml/min at 3 in water back pressure. In some embodiments, the porousstructure 130 is configured to permit a flow rate through the porousstructure 130 of between about 50-12,000 ml/min, between about 75-11000ml/min, between about 100-10000 ml/min, between about 125-9000 ml/min,between about 150-8000 ml/min, between about 175-7050 ml/min, betweenabout 200-6500 ml/min, between about 225-6250 ml/min, between about250-6000 ml/min, between about 275-5750 ml/min, between about 300-5500ml/min, between about 325-5250 ml/min, between about 350-5000 ml/min,between about 375-4750 ml/min, between about 400-4500 ml/min, betweenabout 425-4250 ml/min, between about 450-4000 ml/min, between about475-3750 ml/min, between about 500-3500 ml/min, between about 525-3250ml/min, between about 550-3000 ml/min, between about 575-2750 ml/min,between about 600-2500 ml/min, between 625-2250 ml/min, between about650-2000 ml/min, between about 675-1750 ml/min, or any other flow ratethat facilitates collection of sample from a fluid flowing through thebreath sample capture cartridge 100 as disclosed herein. In someembodiments, the porous structure 130 is configured to permit a flowrate through the porous structure 130 of between about 7000-10000ml/min.

In some embodiments, the porous structure 130 is configured to hold amaterial (e.g., an interactant comprising silica beads) having anaverage particle size of about 80 μm. In some embodiments, the porousstructure 130 is configured to hold a material having an averageparticle size of greater than about 40 μm, greater than about 45 μm,greater than about 50 μm, greater than about 55 μm, greater than about60 μm, greater than about 65 μm, greater than about 70 μm, greater thanabout 75 μm, greater than about 80 μm, greater than about 85 μm, greaterthan about 90 μm, greater than about 95 μm, greater than about 100 μm,greater than about 110 μm, greater than about 120 μm, greater than about130 μm, greater than about 140 μm, greater than about 150 μm, greaterthan about 160 μm, greater than about 170 μm, greater than about 180 μm,greater than about 190 μm, greater than about 200 μm, greater than about220 μm, greater than about 240 μm, greater than about 260 μm, greaterthan about 280 μm, greater than about 300 μm, greater than about 320 μm,greater than about 340 μm, greater than about 360 μm, greater than about380 μm, greater than about 400, or any other size of particle thatadvantageously facilitates sample capture and analysis as disclosedherein. In some embodiments, the pore size of the porous structure 130is larger (e.g., only slightly larger) than the particle size of thematerial to be contained within the porous structure 130. In someembodiments, the pore size of the porous structure 130 is smaller thanthe particle size of the material to be contained within the porousstructure 130.

The material held within the porous structure 130 may be an unreactivebase material or substrate, such as silica, silica gel, silica wool,glass, nitrocellulous, a sodium silicate derivate, or metal oxide, towhich an interactant has been attached to cause the base material tobecome functionalized. The base material may be in the form of particlesof various configurations (e.g., beads), although this need not be thecase. In some embodiments the material contained within the porousstructure 130 is an interactant 120 comprising silica. The silica may befunctionalized with an amine (e.g., aminated). For example, an amine(which may later react with a sample of interest, e.g., an analyte ofinterest) may be bound to the surface of the silica beads or particles.

In some embodiments, the interactant 120 comprises particles of silicathat are substantially round or spherical and have a particle size(e.g., an average particle size) of about 50 μm. In some embodiments theinteractant 120 comprises particles of silica that have a particle size(e.g., an average particle size) of less than about 300 μm, less thanabout 280 μm, less than about 260 μm, less than about 240 μm, less thanabout 220 μm, less than about 200 μm, less than about 180 μm, less thanabout 160 μm, less than about 140 μm, less than about 120 μm, less thanabout 100 μm, less than about 90 μm, less than about 80 μm, less thanabout 70 μm, less than about 60 μm, less than about 50 μm, less thanabout 40 μm, less than about 30 μm, less than about 20 μm, or any otherdiameter that advantageously facilitates sample flow through theinteractant 120 and interaction of the interactant 120 with the analyteof interest contained within the fluid sample. In some embodiments, theinteractant 120 comprising particles of silica have a particle size(e.g., an average particle size) in the range of between about 37-53 μm,between about 53-88 μm, or between about 88-105 μm.

In some embodiments, the quantity of interactant 120 may fill the porousstructure 130 more than about 50%, more than about 55%, more than about60%, more than about 60%, more than about 70%, more than about 75%, morethan about 80%, more than about 85%, more than about 90%, more thanabout 95%, or any other amount that facilitates capture/collection andanalysis of a sample as disclosed herein.

In some embodiments, the volume of interactant 120 contained within theporous structure 130 is less than about 5 ml, less than about 4.5 ml,less than about 4 ml, less than about 3.5 ml, less than about 3 ml, lessthan about 2.5 ml, less than about 2 ml, less than about 1.5 ml, lessthan about 1.4 ml, less than about 1.3 ml, less than about 1.2 ml, lessthan about 1.1 ml, less than about 1 ml, less than about 0.9 ml, lessthan about 0.8 ml, less than about 0.7 ml, less than about 0.6 ml, lessthan about 0.5 ml, less than about 0.4 ml, less than about 0.3 ml, lessthan about 0.2 ml, less than about 0.1 ml, less than about 0.03 ml, orany other volume that facilitates capture/collection and analysis of asample as disclosed herein.

In some embodiments, rather than using silica beads or particles, otherchemistry substrates or base materials are used, such as sodium silicatederivates and/or silica/quartz wool. For example, a 4″×1″ strip ofsilica wool can be put in a solution of 1.6 ml APTES+3.2 ml propanol+3.2ml sulfuric acid and heated to 80° C. for 2 hours and then 110° C. for 1hour. The result is silica wool conjugated with primary amine. Thesesubstrates may have different geometries, such as planar, sheets, etc.(e.g., they may be cut or formed into disks that can be place in theporous structure 130).

FIGS. 3A-3H show various views of an embodiment of a canister 140 of abreath sample capture cartridge 100. FIGS. 3A-3B show distal endperspective views of an embodiment of a canister 140, while FIGS. 3C-3Dshow proximal end perspective views of the canister of FIGS. 3A-3B. FIG.3E shows a distal end view of the canister 140 of FIGS. 3A-3B. FIG. 3Fshows a proximal end view of the canister 140 of FIGS. 3A-3B. FIG. 3Gshows a side view of the canister 140 of FIGS. 3A-3B. FIG. 3H shows across-sectional side view of the canister 140 of FIGS. 3A-3B. As can beseen in the various views of FIGS. 3A-3H, a canister 140 may comprise asubstantially cylindrical shape with a canister cavity 144 formed by theinner wall 141 of the canister 140. The canister may include one or morechannels 142 separated by a plurality of ribs 145 extending radiallyinwardly from the inner wall 141. The one or more channels 142 may allowfor the entry and passage of the sample fluid into and through thebreath sample capture cartridge 100 towards the porous structure 130 andthe interactant 120 it may contain. Therefore, the one or more channels142 may advantageously have characteristics (e.g., shape, size,direction, etc.) that promote thorough and efficient mixing of thesample fluid with the interactant 120 contained within the porousstructure 130. In some embodiments, such efficient mixing is achieved byinducing turbulent flow of the sample fluid. In some embodiments, thechannels 142 are shaped, arranged, and oriented to increase theturbulence of fluid flow and/or mixing of the sample fluid with theinteractant 120 contained in the porous structure 130. In someembodiments, the one or more channels 142 comprises a plurality ofchannels, e.g., 8 channels, or any other number of channels 142 thatpromotes fluid flow through the breath sample capture cartridge 100 andefficient mixing of the sample fluid with the interactant 120 containedin the porous structure 130.

The plurality of ribs 145 of the desiccant cannister 140 may comprisevarious radially inward protrusions along their length, including aproximal protrusion 146, a mid-proximal protrusion 147, a mid-distalprotrusion 148, and/or a distal protrusion 149. In some embodiments andas shown in FIGS. 3A-3D, the canister may include 8 ribs 145, the 8 ribs145 including two proximal protrusions 146, two mid-proximal protrusions147, four mid-distal protrusions 148, and four distal protrusions 149.Further as shown, a rib 145 that includes a proximal protrusion 146 or amid-proximal protrusion 147 may not include any further protrusionsalong its length, while a rib 145 that contains a mid-distal protrusion148 may also include a distal protrusion 149 along its length. Aproximal protrusion 146 may comprise a ramped or curved proximal-facingend and a shelf-like distal-facing end. Likewise, a mid-proximalprotrusion 147 may comprise a ramped or curved proximal-facing end and ashelf-like distal-facing end. A mid-distal protrusion 148 may comprise aramped, curved, or shelf-like proximal-facing end, and a distalprotrusion 149 may comprise a shelf-like proximal-facing end. Thevarious potential interactions of the ribs 145 with protrusions 146,147, 148, and 149 with other components of the breath sample capturecartridge will be described later herein, particularly in reference toFIGS. 5A-5B. Of course, one of ordinary skill in the art will understandthat various modifications to the number and orientation of theprotrusions and ribs may be made compared to the embodiment shown inFIGS. 3A-3H. For example, and in some embodiments, indentations may beutilized along ribs 145 instead of protrusions.

The canister 140, in some embodiments, may have an outer body diameterof between about 0.25″-0.75″, between about 0.275″-0.725″, between about0.3″-0.7″, between about 0.325″-0.675″, between about 0.35″-0.65″,between about 0.40″-0.625″, between about 0.425″-0.60″, between about0.45″-0.575″, between about 0.475″-0.55″, between about 0.475″-0.525″,of about 0.50″, or any other diameter that advantageously facilitatesuse and collection of samples as disclosed herein. The canister 140, insome embodiments, may have a height of about 0.8″. The canister 140, insome embodiments, may have a height of between about 0.4″-1.2″, betweenabout 0.5″-1.1″, between about 0.6″-1.0″, between about 0.7″-0.9″,between about 0.75″-0.85″, or any other height that advantageouslyfacilitates use and collection of samples as disclosed herein.

Referring back to FIG. 1F, the lens cap 110 may be fit onto the canister140. In some embodiments, the lens cap 110 is removablyattached/attachable to the cartridge canister 140. For example, the lenscap 110 may be attached to the canister 140 using threads, friction,clips, detents, springs, j-hooks, etc. In other embodiments, the lenscap 110 is fixedly attached/attachable to the canister 140. For example,the lens cap 110 may be attached to the canister 140 using epoxies,glues, welding (e.g., friction welding, and/or other types of welding),cements, locking threads, clips, co-melting plastics, etc.

In some embodiments, the canister 140 is formed out of a softer material(e.g., polymer or plastic) to facilitate the lens cap 110 slipping overthe top of the canister 140. In some embodiments, an inner wall of thelens cap 110 and an outer wall of an upper portion of the canister 140have an angle (are slightly sloped or conical) to facilitate simple andquick fitment of the lens cap 110 to the canister 140. In someembodiments, the outer wall of the canister 140 has an angle of about 92degrees to the horizontal. In some embodiments, the outer wall of thecanister 140 has an angle of less than about 100 degrees, less thanabout 99 degrees, less than about 98 degrees, less than about 98degrees, less than about 97 degrees, less than about 96 degrees, lessthan about 95 degrees, less than about 94 degrees, less than about 93degrees, less than about 92 degrees, less than about 91 degrees, or anyother angle that facilitate application and/or removal of the lens cap110 from the breath sample capture cartridge 100.

Referring back to FIGS. 1B, 1D, 1F, and 2A-2B, the breath sample capturecartridge may include a piston 160 disposed along its longitudinal axis103. As shown, the piston 160 may include a longitudinal shaft 161, aproximal radial element 163, and a distal radial element 165. Further asshown, in some embodiments, piston 160 may also include a proximal shaftprotrusion 162 and a mid-radial element 164. The proximal radial element163, distal radial element 165, and mid-radial element 164 may comprisea disk-like shape, each with a proximal-facing side, a distal-facingside, and a radially outward-facing side. The radially outward-facingside of the proximal radial element 163, distal radial element 165, andmid-radial element 164 may interact with the radially inward facing ribs145 and any protrusions 146, 147, 148, and 149 they may contain (or, insome embodiments, with any indentations along ribs 145). For example,piston 160 may slidably move along the longitudinal axis 103 of thebreath sample capture cartridge 100 by interaction between the radiallyoutward-facing side of the proximal radial element 163, distal radialelement 165, and mid-radial element 164 with the radially inward facingribs 145 and any protrusions 146, 147, 148, and 149 they may contain. Insome embodiments, and to facilitate sliding movement of the piston 160within the breath sample capture cartridge 100, the radiallyoutward-facing sides of piston radial elements 163, 164, and 165 may besloped or slanted relative to the longitudinal axis 103, and/or compriserounded features.

In some embodiments, the piston 160 may have a longitudinal length ofbetween about 0.5″-0.6″, a longitudinal shaft 161 with a diameter ofbetween about 0.05″-0.11″, a proximal shaft protrusion 162 longitudinallength of between about 0.02″-0.1″, and a proximal radial element 163, amid-radial element 164, and a distal radial element 165 with diametersof between about 0.1″-0.4″.

Referring back to FIGS. 1D, 1F, and 2A-2B, in some embodiments thecartridge canister 140 may contain a desiccant 150 to condition asample-containing fluid before it exits channels 142 and enters theporous structure 130 to react with the interactant 120. As shown inFIGS. 4A-4B, the desiccant 150 may be generally cylindrically shapedwith a central bore and a longitudinal slit 155 extending from thecentral bore through the radial thickness of the desiccant 150. Also asshown, the central bore and longitudinal slit 155 of the desiccant 150may allow for the desiccant to be installed around the piston 160 inbetween a proximal radial element 163 and a mid-radial element 164 ofthe piston 160. In some embodiments, the desiccant 150 may comprise afibrous and/or absorbent material, for example cotton, that can absorbmoisture from the fluid sample. In some embodiments, the desiccant 150may comprise a fibrous and/or absorbent material, for example a highrelease media such as PE and/or PP, that can absorb moisture from thefluid sample.

In some embodiments, desiccant 150 may have an outer diameter of betweenabout 0.100″-0.460″, between about 0.150″-0.410″, between about0.200″-0.360″, between about 0.250″-0.310″, between about 0.270″-0.290″,between about 0.275″-0.285″, of about 0.280″, or any other diameter thatadvantageously facilitates use and collection of samples as disclosedherein. The desiccant 150, in some embodiments, may have a height ofbetween about 0.100″-0.460″, between about 0.150″-0.410″, between about0.200″-0.360″, between about 0.250″-0.310″, between about 0.270″-0.290″,between about 0.275″-0.285″, of about 0.280″, or any other height thatadvantageously facilitates use and collection of samples as disclosedherein. The desiccant 150, in some embodiments, may have a central borediameter of between about 0.050″-0.110″, between about 0.060″-0.100″,between about 0.070″-0.090″, between about 0.075″-0.085″, of about0.081″, or any other diameter that advantageously facilitates use andcollection of samples as disclosed herein.

In some embodiments, the desiccant 150 comprises a radial dimension thatallows for the desiccant 150 to be confined between ribs 145 of thecanister 140. In such embodiments, cannister channels 142 may be furtherdefined by the outer radial dimension of the desiccant 150. In someembodiments, the desiccant 150 comprises a material that conforms aroundany ribs 145 of the canister 140 and extends radially to meet the innerwall 141 of the canister 140. In some embodiments, no desiccant may becontained in the canister 140. The absence of any desiccant in thecanister 140 may advantageously promote improved transfer of fluid flowfrom the channels 142 to the porous structure 130, through the porousstructure base 134 and into the interactant 120 contained within theporous structure 130. That is, no desiccant 150 within canister 140 mayallow better fluid flow and mixing to occur in the interactant 120because the fluid flow leaving the channels 142 is not impeded by amaterial or partially impeded by a material.

Referring back to FIGS. 1F and 2A-2B, in some embodiments the breathsample capture cartridge 100 may include a reservoir 170 containing adeveloper solution 175. The reservoir may comprise a fibrous, absorbent,and/or sponge-like material that can contain the developer solution 175until it is compressed by the piston 160 as described herein(particularly with reference to FIGS. 6A-6B later). The reservoir 170may, for example, be formed from a fibrous material that can serve as ahigh release media; for instance, the reservoir 170 may be formed as abonded fiber reservoir containing fibers of polyethylene (PE) andpolypropylene (PP). The reservoir 170 can be pre-soaked with thedeveloper solution 175, and compression of the reservoir 170 can causethe developer solution 175 to seep out. The reservoir 170 may comprise agenerally cylindrical shape, with a height and a radius. The height ofthe reservoir 170 may be dimensioned such that it may fit in asubstantially uncompressed state between the distal side of the distalradial element 165 of piston 160 and the shelf-like proximal-facing endof the distal protrusion 149 of the canister 140. In some embodiments,the height of the reservoir 170 may be about 0.157″. In someembodiments, the height of the reservoir 170 may be between about0.05″-0.25″, between about 0.75″-0.225″, between about 0.1″-0.2″, or anyother height that allows the reservoir to fit in a substantiallyuncompressed state between the distal side of the distal radial element165 of piston 160 and the shelf-like proximal-facing end of the distalprotrusion 149 of the canister 140. The diameter of the reservoir 170may be dimensioned such that it may fit in a substantially uncompressedstate between ribs 145 of the canister 140. In some embodiments, thereservoir 170 may have a diameter of about 0.250″. In some embodiments,the reservoir 170 may have a diameter of between about 0.15″-0.350″,between about 0.175″-0.325″, between about 0.2″-0.3″, between about0.225″-0.275″, or any other diameter that allows the reservoir to fit ina substantially uncompressed state between ribs 145 of the canister 140.

In some embodiments, the developer solution 175 contained within thereservoir 170 may be viscous. In some embodiments, the developersolution 175 is light sensitive. In some embodiments, the developersolution 175 produces a residue upon drying. In some embodiments, thedeveloper solution 175 has a low boiling point. In some embodiments, thedeveloper solution 175 is flammable. In some embodiments, the developersolution 175 may suffer from all of these limitations: it may becomparatively viscous, be flammable, have UV-light sensitivity, producea crust-like residue (post dry-out), and/or have a low boiling point(which may cause pressurization or negative pressure within any rigidstorage vessel). Breath sample capture cartridges 100 as disclosedherein may address each of these specialized needs.

In some embodiments, the developer solution 175 may be a mixture ofmethanol (which can serve as a solvent), DMSO (which can serve as astabilizing agent), and sodium nitroprusside (SNP). Various othersolvents can be used in place of methanol, such as glycerol, methyllactate, ethyl lactate, or butyl lactate. In the case of acetonemeasurement, the SNP in the developer solution reacts with imines thatare formed in porous structure 130 from acetone in the breath samplebonding with the interactant 120 in the porous structure 130. Thisreaction produces the measurable color change used to measure thequantity of extracted acetone, and thus the concentration of acetone inthe breath sample. In some embodiments, developer solutions 175containing or comprising entirely different ingredients or componentsmay be used.

In some embodiments, the reservoir 170 disclosed herein may contain avolume of developer solution 175 of about 80 μL. In some embodiments,the reservoir 170 may contain a volume of developer solution 175 ofbetween about 0.5-1.1 μL, between about 0.6-1.0 μL, between about0.65-0.95 μL, between about 0.7-0.9 μL, between about 0.75-0.85 μL, orany other volume sufficient to interact with interactant 120 for analytedetection.

Referring back to FIG. 1F, in some embodiments, a breath sample capturecartridge 100 in the assembled and unused state may comprise alongitudinal gap 180 between a distal end of the reservoir 170containing the developer solution 175 and the proximal end of the porousstructure 130 (e.g., the proximal side of the porous structure base134). The gap 180 may prevent the developer solution 175 frominteracting with the interactant 120 and/or porous structure 130 beforedesired. In some embodiments, the gap 180 may have a longitudinaldimension of between about 0.25-4 mm or any dimension that may preventthe developer solution 175 contained within the reservoir 170 frominteracting with the interactant 120 and/or porous structure 130 beforedesired.

As discussed above, in some embodiments the breath sample capturecartridge 100 includes an intermediate layer disposed between the porousstructure 130 and the reservoir 170 (e.g., disposed within the gap 180).Such an intermediate layer can aid in preventing the developer solution175 from interacting with the interactant 120 and/or porous structure130 before desired. The intermediate layer can be configured to transferthe developer solution 175 from the reservoir 170 to the porousstructure 130 and/or interactant 120 when desired. The intermediatelayer can also be configured so as not to substantially restrict fluidflow through the breath sample capture cartridge 100. For example, theintermediate layer can be configured to allow a fluid flow rate that isgreater than the porous structure 130. In some embodiments, theintermediate layer comprises a porous material. In such embodiments, thepores of the intermediate layer can be larger than the pores of theporous structure 130. The intermediate layer can have a longitudinaldimension of between about 0.25-4 mm. In some embodiments, a proximalend of the intermediate layer abuts the reservoir 170, and a distal endof the intermediate layer abuts the porous structure 130 (e.g., theintermediate layer completely fills the gap 180). In some embodiments, adistal end of the intermediate layer abuts the porous structure 130 anda space is left between a proximal end of the intermediate layer and thereservoir 170. In some embodiments, the intermediate layer can be shapedand sized such that it can float within the gap 180 and not directly orsubstantially abut the porous structure 130 or the reservoir 170.

In regard to the flow path of a fluid sample within a breath samplecapture cartridge 100, it can be understood with reference to FIG. 1Fthat in at least one embodiment, the continuous flow path proceeds fromthe proximal end of the breath sample capture cartridge 100, into theone or more channels 142 of the canister 140, through the one or morechannels 142 (and in some embodiments, also through the desiccant 150held by the piston 160), through the intermediate layer if included (notshown in FIG. 1F), through the porous structure base 134 of the porousstructure 130, through the interactant 120, through the sides of theporous structure 130, and out through the lens cap vents 114. Of course,one of ordinary skill in the art will understand that variousmodifications to this flow path may be made.

Referring to FIGS. 4A-4B, shown are proximal end and distal endperspective views of an embodiment of a desiccant 150 and a reservoir170 in relation to a piston 160 of a breath sample capture cartridge. Asdescribed herein and according to some embodiments, the desiccant 150may be disposed surrounding the longitudinal shaft 161 of piston 160between proximal radial element 163 and mid-radial element 164.Furthermore, the reservoir 170 may be disposed distal to the distalradial element 165 of the piston 160.

Referring to FIGS. 5A-5B, shown are cross-sectional views of anembodiment of a breath sample capture cartridge 100 with a piston 160 attwo positions along a longitudinal axis 103 of the breath sample capturecartridge 100 with a desiccant 150 and a reservoir 170 removed fromview. FIG. 5A shows the piston 160 in a first position (e.g., a proximalposition), which may correspond to a breath sample capture cartridge 100in an unused and/or new state. FIG. 5B shows the piston 160 in a secondposition (e.g., a distal position) advanced distally along longitudinalaxis 103 within the breath sample capture cartridge 100, which maycorrespond to a breath sample capture cartridge 100 in a used and/oractivated state.

As shown in FIG. 5A, in some embodiments the piston 160 may be heldrelatively in place in the first position by interaction of the proximalside of the proximal radial element 163 of piston 160 with theshelf-like distal-facing end of proximal protrusion 146 of a rib 145 ofthe canister 140 and the distal side of the proximal radial element 163with the ramped or curved proximal-facing end of mid-proximal protrusion147 of a rib 145. For example, the piston 160 may be prevented fromtranslating substantially distally or proximally by the interaction ofthe proximal radial element 163 with protrusions 146 and 147 of ribs145. In some embodiments (not shown), the piston 160 may be preventedfrom translating substantially distally or proximally by the interactionof the proximal radial element 163 with indentations in one or more ribs145.

As shown in FIG. 5B, in the process of a user obtaining a breath sampleanalysis as described herein, the piston 160 may be translated distallyalong the longitudinal axis 103 of the breath sample capture cartridge100 to a second position. To translate distally, a longitudinal force inthe distal direction may be applied to the piston 160 at its proximalend, such as to and/or around proximal shaft protrusion 162, to causethe proximal radial element 163 of piston 160 to slide over the rampedor curved proximal-facing end of mid-proximal protrusion 147 andsubstantially lock into place within the breath sample capture cartridge100. To lock in place, the proximal side of the proximal radial element163 may interact with the shelf-like distal-facing end of mid-proximalprotrusion 147. As such, once a user causes distal translation of thepiston 160 within the breath sample cartridge 100, sustained force maynot be required to keep the piston 160 in the second position. In someembodiments, distal translation of piston 160 within the breath samplecartridge 100 may be limited by the shelf-like proximal-facing end ofdistal protrusion 149 and/or the ramped or curved proximal-facing end ofmid-distal protrusion 148. In some embodiments (not shown), indentationsof ribs 145 may lock piston 160 in place and limit distal translation ofpiston 160 within the breath sample cartridge 100.

Referring to FIGS. 6A-6B, shown are schematic views of an embodiment ofa piston 160 causing a developer solution 175 of a reservoir 170 to passthrough a porous structure 130 supporting an interactant 120 and comeinto contact with the interactant 120. As shown in FIG. 6A and accordingto some embodiments as described herein, prior to translation of thepiston 160, a gap 180 is formed between the reservoir 170 and the porousstructure 130 supporting the interactant 120 (this may, for example,correspond to the first position of piston 160 as described in relationto FIGS. 5A-5B). As shown in FIG. 6B and according to some embodimentsas described herein, translation of the piston 160 towards the porousstructure 130 causes the reservoir 170 to come into contact with theporous structure 130, causing developer solution 175 to come intocontact with the porous structure 130, and causing the developersolution 175 held by the reservoir to flow into the porous element 130and contact interactant 120 (this may, for example, correspond to thesecond position of piston 160 as described in relation to FIGS. 5A-5B).In some embodiments, the flow of developer solution 175 occurs bycapillary action or wicking, and does not rely on gravity to properlywet the porous structure 130 and interactant 120; thus, the porousstructure 130 and interactant 120 are properly wetted regardless of theorientation of the illustrated assembly. Alternatively, or in addition,the developer solution 175 flows and/or seeps out of the reservoir 170upon compression by the piston 160. In some cases (not shown), anintermediate layer as described herein can be disposed within the gap180 between the reservoir 170 and the porous structure 130. In suchcases, translation of the piston 160 towards the porous structure 130can cause the reservoir 170 to come into contact with the intermediatelayer, causing the developer solution 175 held by the reservoir to flowinto the intermediate layer which can transmit the developer solution175 to the porous structure 130 and interactant 120. In someembodiments, a color change or other optical change induced by thedeveloper solution 175 is measured through the lens 112 by an opticalsubsystem (not shown). For example, one or more LEDs may illuminate theinteractant 120 and/or porous structure 130 through the lens 112 while aphotodiode measures the light reflected from the interactant 120 and/orthe porous structure 130. One example of a photodiode/LED assembly andprocess that may be used in the various embodiments disclosed herein isdisclosed in U.S. Pat. No. 10,782,284, the disclosure of which is herebyincorporated by reference and should be considered a part of thisspecification.

Breath Analysis Device

FIGS. 7A-7B, 8A-8B, and 9A-9G illustrate an embodiment of a breathanalysis device 200 that may be used in conjunction with a breath samplecapture cartridge 100, as disclosed herein, to collect and analyze afluid sample (e.g., a breath sample). FIGS. 7A-7B show various views ofan embodiment of a breath analysis device 200 with a breath samplecartridge 100 removed from the breath analysis device 200. FIG. 7A showsa proximal end top perspective view and FIG. 7B shows a distal end topperspective view. FIGS. 8A-8B show various views of an embodiment of abreath analysis device 200 with a breath sample cartridge 100 installedin the breath analysis device 200. FIG. 8A shows a proximal end topperspective view and FIG. 8B shows a distal end top perspective view.

As shown in FIGS. 7A-7B and 8A-8B, in some embodiments the breathanalysis device 200 may comprise a mouthpiece 300 disposed at itsproximal end, a housing 205, a slider 270 with a slider button 275disposed at an upper surface of the housing 205, and a cartridgeinsertion window 240 disposed distal to the slider 270 for receiving thebreath sample capture cartridge 100. As shown in FIGS. 7A-7B, the slider270 is in a proximal position, which has caused a slideable door 250(not shown) to be recessed within the housing 205 and thus exposing thecartridge insertion window 240 for receiving and/or removing of a breathsample capture cartridge 100. As shown in FIGS. 8A-8B, the breath samplecartridge 100 is installed in the breath analysis device 200 and theslider 270 is in a middle position, which has caused components of thebreath analysis device 200 to form a seal (e.g., substantially air-tightseal) with the proximal end of the breath sample cartridge 100; in someembodiments, the slideable door 250 may close over the breath samplecartridge 100 when the slider 270 is its middle position, however it hasbeen removed from view to show how the breath sample cartridge 100 mayfit within the breath analysis device 200.

FIGS. 9A-9D show various views of an embodiment of a breath analysisdevice. FIG. 9A shows a top view of an embodiment of a breath analysisdevice with the slideable door 250 in its closed position. As shown, avent 255 may be formed between the slideable door 250 and the housing205 when the slideable door 250 is in its closed position. FIG. 9B showsa side view of the breath analysis device of FIG. 9A. FIG. 9C shows aproximal end view of the breath analysis device of FIG. 9A and furthershows a mouthpiece inlet opening 330. FIG. 9D shows a distal end view ofthe breath analysis device of FIG. 9A and further shows a power switch290 and a charge port 280.

FIG. 9E shows a cross-sectional side view of the breath analysis device200 of FIG. 9A without a breath sample capture cartridge 100 installed.FIG. 9F shows a cross-sectional side view of the breath analysis device200 of FIG. 9A with a breath sample capture cartridge 100 installed.FIG. 9G shows a proximal end cross-sectional perspective view of thebreath analysis device 200 of FIG. 9A without a breath sample capturecartridge 200 installed. According to FIGS. 9E-9G, in addition to thebreath analysis device 200 components mentioned with respect to FIGS.7A-7B, 8A-8B, and 9A-9D, the breath analysis device 200 may furthercomprise a filter 210, an airbox 220, an airbox sealing element 225, anairbox gasket 227, a main PCB 208, a sled 230, a cartridge gasket 235, acradle 245, an aperture 260, LEDs 263 (not shown), a detector 265 (notshown), and a battery 295.

In some embodiments and according to FIGS. 9E-9G, the filter 210 may bedisposed between the mouthpiece 300 and the airbox 220. The filter 210may comprise a fibrous material and may capture moisture and/or debrisfrom the sample fluid.

In some embodiments, the airbox 220 may comprise a generally cylindricalinner cavity (which may comprise one or multiple different diameters)and lie along a longitudinal axis of the breath analysis device 200. Insome embodiments, a proximal end of the airbox 220 may seal (e.g., anairtight or substantially airtight seal) with the mouthpiece 300 and theinner cavity of the airbox 220 may be fluidly connected to themouthpiece inlet opening 330. In some embodiments, a distal end of theairbox may seal (e.g., an airtight or substantially airtight seal) withthe sled 230 via the airbox sealing element 225 (e.g., an O-ring). Insome embodiments, the airbox 220 may comprise an open wall adjacent themain PCB 208, the open wall substantially sealed (e.g., an airtight orsubstantially airtight seal) via the airbox gasket 227 disposed betweenthe airbox 220 and the main PCB 208.

In some embodiments, the main PCB 208 may comprise, within the area ofthe main PCB defined by airbox gasket 227 that is exposed to theinternal cavity of the airbox 220, sensing elements and/or emitters, forexample, flow sensors, moisture sensors, LEDs, and the like, for sensingaspects of the fluid sample and/or for signaling a user. In someembodiments, a flow sensor may detect that a gas-tight seal is not madebetween the breath analysis device 200 and the breath capture samplecartridge 100 and prevent a test and/or fluid sample from being taken.In some embodiments, the main PCB 208 may comprise a processor. In someembodiments, the main PCB 208 may comprise a controller. In someembodiments, the main PCB 208 may receive power from battery 295. Insome embodiments, the main PCB 208 may comprise a wireless transceiverfor communicating wirelessly with other electronic devices, such as acell phone, computer, and/or servers, via a wireless network and/or alow energy RF connection (e.g., Bluetooth communication). In someembodiments, the main PCB 208 may comprise a speaker and/or a motorconfigured to provide auditory and/or haptic signals to a user. In someembodiments, the main PCB 208 may comprise sensor circuitry and/orcomponents for analyzing a breath sample capture cartridge 100. In someembodiments, elements of the main PCB 208 may be in communication withone another. In some embodiments, the breath analysis device 200 mayfurther comprise a daughter PCB, which may have all or some of thecomponents of the main PCB 208 and may be in electrical communicationwith the main PCB 208.

In some embodiments, the sled 230 may comprise a generally longitudinalstructure that may translate proximally and distally within the breathanalysis device 200. In some embodiments, the sled 230 may translateproximally and distally within the breath analysis device 200 viaproximal and distal movement of the slider 270. In some embodiments, thesled 230 may translate further distally within the breath analysisdevice 200 via proximal and distal movement of the slider 270 incombination with the slider button 275 being pressed inward towards thelongitudinal axis of the breath analysis device 200; for example, thisfurther distal translation may allow for distal longitudinal force to betransferred to the breath sample capture cartridge 100 and/or componentsthereof (e.g., the piston 160). In some embodiments, the sled 230 maycomprise an inner cavity fluidly connected to the inner cavity of theairbox 220. In some embodiments, a distal end of the sled 230 may beconfigured to interact with the proximal end of a breath sample capturecartridge 100. In some embodiments, the distal end of the sled 230 maybe configured to engage the proximal shaft protrusion 162 of piston 160of the breath sample capture cartridge 100; such engagement may retainthe breath sample capture cartridge 100 in place within the cradle 245and allow for the transmission of longitudinal force from the slider 270to the piston 160. In some embodiments, a distal section of the sled 230may be surrounded by the cartridge gasket 235, and the inner cavity ofthe sled 230 may be in fluid communication with an internal cavity ofthe cartridge gasket 235. In some embodiments, the distal section of thesled 230 may align or substantially align longitudinally with thelongitudinal axis 103 of the breath sample capture cartridge 100.

In some embodiments, the cartridge gasket 235 may be a generallyflexible, collapsible, and tubular structure with an internal cavity asmentioned above. In some embodiments, the cartridge gasket 235 maycomprise an elastomeric and bellowed structure. In some embodiments, thecartridge gasket 235 may, at its proximal end, seal (e.g., an airtightor substantially airtight seal) around and/or against the distal sectionof the sled 230, thus creating fluid communication between the internalcavity of the cartridge gasket 235 and the internal cavity of the sled235. In some embodiments, the cartridge gasket 235 may, at its distalend, seal (e.g., an airtight or substantially airtight seal) with theproximal end of the breath sample capture cartridge 100. In someembodiments, via a seal between the distal end of the cartridge gasket235 and the proximal end of the breath sample capture cartridge 100, theinternal cavity of the cartridge gasket 235 may be in fluidcommunication with the one or more channels 142 of the breath samplecapture cartridge 100.

In some embodiments, the cradle 245 may be disposed generally distal tothe sled 230 and comprise a surface for receiving the breath samplecapture cartridge 100. In some embodiments, a distal portion of thesurface of the cradle 245 may comprise distally inclining wings thatcreate a partially cylindrically-shaped surface of the cradle 245 andmay support the breath sample capture cartridge 100 once installed. Insome embodiments, a distal end of the cradle 245 may comprise a recess247 that can receive the distal end of the breath sample capturecartridge 100. In some embodiments, the recess 247 may prevent thebreath sample capture cartridge 100 from being installed incorrectly. Insome embodiments, the recess 247 may prevent distal translation of thebreath sample capture cartridge 100 when distal longitudinal force isapplied to the proximal end of the breath sample capture cartridge 100and/or components of the breath sample capture cartridge 100 (e.g.,piston 160). In some embodiments, the surface of the cradle 245 maycomprise features that can prevent the breath sample capture cartridge100 from being installed incorrectly. For example, the surface of thecradle 245 may comprise features that can prevent the breath samplecapture cartridge 100 from fully seating into the cradle 245 if notinstalled correctly (e.g., installed backwards) and prevent closure ofthe slideable door 250 (which, if not closed, may not allow the breathsample device 200 to start a test and/or receive a fluid sample). Insome embodiments, the cartridge insertion window 240 is disposed abovethe cradle 245. In some embodiments, the cradle 245 containing thebreath sample capture cartridge 100 (e.g., after the breath samplecapture cartridge 100 was placed in through the cartridge insertionwindow 240) may have dimensions, e.g., height, width, and/or depth,slightly larger than the breath sample capture cartridge 100. In someembodiments, at least one of the height, width, or depth, is larger thanthe corresponding dimension of the breath sample capture cartridge 100by at least about 101%, at least about 102%, at least about 103%, atleast about 104%, at least about 105%, at least about 106%, at leastabout 107%, at least about 108%, at least about 109%, at least about110%, at least about 112.5%, at least about 115%, at least about 117.5%,at least about 120%, or any other increase in size that advantageouslyfacilitations acceptance and temporary retention of a breath samplecapture cartridge 100 as disclosed herein.

In some embodiments, the aperture 260 may be disposed distal to thecradle 245 and thus adjacent to lens 112 of the breath sample capturecartridge 100 when installed in the breath analysis device 200. Detailsof the aperture 260, LEDs 263 (not shown), and detector 265 (e.g. aphotodiode, not shown) may be as described in U.S. Pat. No. 10,782,284,the disclosure of which is already incorporated by reference herein andshould be considered a part of this specification. In some embodiments,the detector 265 (e.g., photodiode) may be programmed to prevent a testand/or a fluid sample from being taken if it detects too much lightcaused from an open slideable door 250.

FIGS. 10A-10J show various views of an embodiment of a mouthpiece 300 ofa breath analysis device. FIG. 10A shows a proximal end top perspectiveview of an embodiment of a mouthpiece 300 of a breath analysis device.FIG. 10B shows a proximal end bottom perspective view of the mouthpiece300 of FIG. 10A. FIG. 10C shows a distal end top perspective view of themouthpiece 300 of FIG. 10A. FIG. 10D shows a distal end bottomperspective view of the mouthpiece 300 of FIG. 10A. FIG. 10E shows a topview of the mouthpiece 300 of a FIG. 10A. FIG. 10F shows a bottom viewof the mouthpiece 300 of FIG. 10A. FIG. 10G shows a proximal end view ofthe mouthpiece 300 of FIG. 10A. FIG. 10H shows a distal end view of themouthpiece 300 of FIG. 10A. FIG. 10I shows a side view of the mouthpiece300 of FIG. 10A. FIG. 10J shows a cross-sectional side view of themouthpiece 300 of FIG. 10A.

As shown through FIGS. 10A-10J, the mouthpiece 300 may comprise amouthpiece body 305 with a proximal end 302, a distal end 301, avertical height, a horizontal width, and a horizontal length. Themouthpiece body 305 may terminate at the proximal end 302 in an upperlip surface 310 and a lower lip surface 320. In some embodiments and asshown, the upper lip surface 310 and the lower lip surface 320 mayextend generally horizontally across substantially the entire horizontalwidth of the mouthpiece body 305. In some embodiments and as shown, thevertical height between the upper lip surface 310 and the lower lipsurface 320 may be less than the vertical height of the mouthpiece body305 at the distal end 301. Also as shown through FIGS. 10A-10J, themouthpiece 300 may comprise an inlet opening 330 at the proximal end 302of the mouthpiece body 305, the inlet opening 330 having a verticalheight and a horizontal width. In some embodiments, the horizontal widthof the inlet opening 330 is greater than the vertical height. Further asshown through FIGS. 10A-10J, the mouthpiece 300 may comprise an outletopening 340 within the mouthpiece body 305, the outlet opening 340 beingin fluid communication with inlet opening 330 of the mouthpiece body305. The mouthpiece outlet opening 340 may be in fluid communicationwith an internal passage and/or inner cavity of the breath analysisdevice 200 (e.g., the internal cavity of airbox 220).

In some embodiments and as shown through FIGS. 10A-10J, the mouthpiecebody 305 of mouthpiece 300 may further comprise an upper transitionsurface 350 extending lengthwise from the upper lip surface 310 towardthe distal end 301, and a lower transition surface 360 extendinglengthwise from the lower lip surface 320 toward the distal end 301. Insome embodiments, the upper transition surface 350 and the lowertransition surface 360 may be partially vertically inclined and extendacross substantially the entire width of the mouthpiece body 305. Insome embodiments, the upper transition surface 350 and the lowertransition surface 360 may comprise smooth, concave surfaces extendingacross substantially the entire width of the mouthpiece body 305.

In some embodiments and as shown through FIGS. 10A-10J, the uppertransition surface 350 may face in a generally proximal and upwarddirection and the lower transition surface 360 may face in a generallyproximal and downward direction. Further as shown, in some embodimentsthe mouthpiece body 305 may comprise upper side edges 370 partiallysurrounding the upper transition surface 350 and the upper lip surface310 and lower side edges 380 partially surrounding the lower transitionsurface 360 and the lower lip surface 320.

In some embodiments and as shown through FIGS. 10A-10J, the mouthpiecebody 305 may comprise a substantially constant width over substantiallyan entire length of the upper transition surface 350 and the lowertransition surface 360.

In some embodiments and as shown through FIGS. 10A-10J, the uppertransition surface 350 and the lower transition surface 360 of themouthpiece body 305 may be partially vertically inclined at an angle ofabout 45 degrees. In some embodiments, the upper transition surface 350and the lower transition surface 360 of the mouthpiece body 305 may bepartially vertically inclined at an angle of between about 30 and about90 degrees relative to a horizontal plane.

In some embodiments, the upper lip surface 310 and the lower lip surface320 of the mouthpiece body 305 may be substantially smooth. In someembodiments, the upper lip surface 310 may have a generally crescentshape and the lower lip surface 320 may have a generally crescent shape.

In some embodiments and as shown through FIGS. 10A-10J, the inletopening 330 of the mouthpiece body 305 may be positioned midway alongthe vertical height of the mouthpiece body 305. In some embodiments, theinlet opening 330 of the mouthpiece body 305 may be positioned above orbelow a midway point along the vertical height of the mouthpiece body305. In some embodiments, the inlet opening 330 of the mouthpiece body305 may comprise an obround shape. In some embodiments, the inletopening 330 of the mouthpiece body 305 may comprise a rectangular shape,an oval shape, or a polygonal shape.

In some embodiments, the horizontal width of the inlet opening 330 maybe about 0.72″. In some embodiments, the horizontal width of the inletopening 330 may be between about 0.70″ and about 1.00″. In someembodiments, the vertical height between the upper lip surface 310 andthe lower lip surface 320 may be about 0.26″. In some embodiments, thevertical height between the upper lip surface 310 and the lower lipsurface 320 may be between about 0.19″ and about 0.4″. In someembodiments, the vertical height of the mouthpiece body 305 at thedistal end 301 may be about 1.22″. In some embodiments, the verticalheight of the mouthpiece body 305 at the distal end 301 may be betweenabout 0.88″ and about 1.50″. In some embodiments, the horizontal widthof the mouthpiece body 305 from the distal end 301 and oversubstantially the entire length of the mouthpiece body 305 to theproximal end 302 may be about 1.37″. In some embodiments, the horizontalwidth of the mouthpiece body 305 from the distal end 301 and oversubstantially the entire length of the mouthpiece body 305 to theproximal end 302 may be between about 0.88″ and about 1.50″. In someembodiments, the horizontal length of the mouthpiece body 305 may beabout 1.06″. In some embodiments, the horizontal length of themouthpiece body 305 may be between about 0.63″ and about 1.50″. In someembodiments, the mouthpiece body 305 may comprise a generallytrapezoidal transverse cross-sectional shape. In some embodiments, theinlet opening 330 may comprise an interior passage 335 having an upperinterior surface 336 and a lower interior surface 337. In someembodiments, the upper interior surface 336 and the lower interiorsurface 337 of the interior passage 335 may be substantially parallel tothe upper lip surface 310 and the lower lip surface 320, respectfully.

According to some embodiments, the features of the mouthpiece 300described herein may facilitate a substantially air-tight seal between auser's mouth and the mouthpiece 300 when in use. In some embodiments, asubstantially air-tight seal between a user's mouth and the mouthpiece300 comprises a substantially air-tight seal between a user's mouth andthe mouthpiece inlet opening 330. In some embodiments, a substantiallyair-tight seal between a user's mouth and the mouthpiece 300 comprises asubstantially air-tight seal between a user's mouth and the mouthpieceinlet opening 330 that fluidly connects a user's mouth to the inletopening 330. The various dimensions and features of embodiments of themouthpiece 300 described herein may allow a user to blow into themouthpiece 300 without a need (or without a substantial need) to utilizeand/or activate muscles of the mouth to form a substantially air-tightseal when in use. For example, the upper transition surface 350 and thelower transition surface 360 may be pressed against the user's upper andlower lips, respectively, to form a substantially air-tight seal withoutthe need for the user to utilize and/or activate muscles of their mouth.As another example, both the upper lip surface 310 and the uppertransition surface 350 along with both the lower lip surface 320 and thelower transition surface 360 may be pressed against the user's upper andlower lips, respectively, to form a substantially air-tight seal withoutthe need for the user to utilize and/or activate muscles of their mouth.

While embodiments of the breath sample device 200 illustrated in FIGS.7A-9G are constructed of the mouthpiece 300 and a separate devicehousing 205, other embodiments may construct the mouthpiece 300 and thedevice housing 205 from a unitary structure, or from more than twoseparate structures. As shown in FIGS. 9E-9G, in some embodiments themouthpiece 300 may be interference fit to the airbox 220 and form asubstantially leak-free air seal. For embodiments wherein the mouthpiece300 may by removably attachable to the breath sample device 200, distalcomponents of the mouthpiece 300 may be lengthened to allow for asealing member (e.g., an o-ring) to fit in the interface between themouthpiece 300 and the airbox 220. Similarly, for embodiments whereinthe mouthpiece 300 may by removably attachable to the breath sampledevice 200, a proximal end of the airbox 220 may be lengthened to allowfor a sealing member (e.g., an o-ring) to fit in the interface betweenthe mouthpiece 300 and the airbox 220. In some embodiments wherein themouthpiece 300 may by removably attachable to the breath sample device200, distal components of the mouthpiece 300 that interact with theairbox 220 may increase in diameter to allow for a sealing member (e.g.,an o-ring) to fit between the mouthpiece 300 and the airbox 220 to forma substantially air-tight seal. In some embodiments wherein themouthpiece 300 may by removably attachable to the breath sample device200, the proximal end of the airbox 220 that interact with the distalend of the mouthpiece 300 may decrease in diameter to allow for asealing member (e.g., an o-ring) to fit between the mouthpiece 300 andthe airbox 220 to form a substantially air-tight seal. In someembodiments wherein the mouthpiece 300 may by removably attachable tothe breath sample device 200, distal components of the mouthpiece 300that interact with the airbox 220 may decrease in diameter to allow fora sealing member (e.g., an o-ring) to fit between the mouthpiece 300 andthe airbox 220 to form a substantially air-tight seal. In someembodiments wherein the mouthpiece 300 may by removably attachable tothe breath sample device 200, the proximal end of the airbox 220 thatinteract with the distal end of the mouthpiece 300 may increase indiameter to allow for a sealing member (e.g., an o-ring) to fit betweenthe mouthpiece 300 and the airbox 220 to form a substantially air-tightseal. In some embodiments, a removably attachable mouthpiece 300 mayfacilitate cleanliness, hygiene, and a change of filter 210 for a userof the breath sample device 200 and/or allow for cleaning of themouthpiece 300 and a change of filter 210 between different users.

In some embodiments, a sample fluid may enter the breath analysis device200 through the mouthpiece inlet opening 330, travel distally throughthe mouthpiece interior passage 335, through the mouthpiece outletopening 340, through the filter 210, through the airbox 220, past themain PCB 208 and the airbox gasket 227, through the sled 230, throughthe cartridge gasket 235, through the breath sample analysis capturecartridge 100 as described herein, and out vent 255.

The breath analysis device 200 may be a portable, small, and hand-helddevice. In some embodiments, the breath analysis device 200 may have alength from the proximal end of the mouthpiece body 305 to the distalend of the housing 205 inclusive of the power switch 290 of about 6.04″.In some embodiments, the breath analysis device 200 may have a lengthfrom the proximal end of the mouthpiece body 305 to the distal end ofthe housing 205 inclusive of the power switch 290 of between about 4″and about 8″. In some embodiments, the breath analysis device 200 mayhave a vertical height inclusive of slider 270 and slider button 275 ofabout 1.32″. In some embodiments, the breath analysis device 200 mayhave a vertical height inclusive of slider 270 and slider button 275between about 0.8″ and 2″. In some embodiments, the breath analysisdevice 200 may have a horizontal width of about 1.37″. In someembodiments, the breath analysis device 200 may have a horizontal widthof between about 0.8″ and 2″. In some embodiments, the breath analysisdevice 200 housing 205 may comprise a generally trapezoidal transversecross-sectional shape.

Methods of Performing a Breath Analysis

A method of performing a breath analysis by a user may comprise:powering on the breath analysis device 200 using the power switch 290;sliding the slider 270 proximally to cause the slideable door 250 toopen and expose the cradle 245; installing the breath sample capturecartridge 100 into the breath analysis device 200 through the cartridgeinsertion window 245 and onto the cradle 245; sliding the slider 270distally to cause the slideable door 250 to close; blowing into themouthpiece 300; pushing the slider button 275 inward; sliding the slider270 distally while pushing the slider button 275 inward; sliding theslider 270 proximally to open the slideable door 250; removing thebreath sample capture cartridge 100; sliding the slider 270 distally tocause the slideable door 250 to close; and powering off the breathanalysis device 200 using the power switch 290. In some embodiments, themethod may include the breath analysis device 200 communicating with anapplication on another electronic device, such as a phone. In someembodiments, the method may include the breath analysis device 200communicating with an application on another electronic device, such asa phone, with the another electronic device performing and reporting thebreath sample analysis.

In some embodiments, to perform a breath analysis a user may use thebreath sample device 200 in combination with another electronic device,such as a phone. In some embodiments, the another electronic device mayhave an application used for guiding, analyzing, and/or reporting thebreath analysis. In some embodiments, the another electronic device mayhave an application used for providing various instructions at variousstages of use of the breath analysis device 200. In some embodiments, amethod to perform a breath analysis using the breath sample device 200and the breath sample capture cartridge 100 as described hereincomprises: powering on the breath analysis device 200 using the powerswitch 290; opening the application and wirelessly connecting the breathanalysis device 200 to the application; sliding the slider 270proximally causing the slideable door 250 to open and reveal thecartridge insertion window 240 and the cradle 245; installing the breathsample capture cartridge 100 into the breath analysis device 200 throughthe cartridge insertion window 245 and onto the cradle 245 with the lenscap 110 oriented distally; sliding the slider 270 distally to cause theslideable door 250 to close, which may cause the breath analysis device200 to communicate with the application to check that the breath samplecapture cartridge 100 is new/unused; blowing into the mouthpiece 300 ofthe breath analysis device 200, which may comprise the breath/fluidsample flowing through the breath analysis device 200 and into thebreath sample capture cartridge 100 and causing the breath/fluid sampleto interact with the interactant 120, and which may also comprise firstblowing for about three seconds not into the mouthpiece 300 thencontinuing to blow out to finish the breath/exhale into the mouthpiece300 until the breath analysis device 200 makes an indication to theuser, such as an audible beep or tone and/or flash or flashes of light,once a volume threshold has been met (this method may allow for thecapture of a lower lung sample and/or alveolar breath/air sample);pushing the slider button 275 inward and while holding inward slidingthe slider 270 distally, which may cause the developer solution 175 tointeract with the interactant 120 within the breath sample capturecartridge 100; allowing the application to communicate with the breathanalysis device 200 and perform the breath analysis with the breathanalysis device 200; sliding the slider 270 proximally to cause theslideable door 250 to open; removing the used breath capture samplecartridge 100; sliding the slider 270 distally to cause the slideabledoor 250 to close; receiving analysis results from the application; andpowering off the breath analysis device 200 using the power switch 290.

The breath analysis process may include the use of a sensor, which maycomprise LEDs 263 and detector 265 (e.g., a photodiode) within thebreath analysis device 200 for measuring a color change, or otheroptical change, produced by a chemical reaction within the breathcapture sample cartridge 100. In some embodiments, the LEDs 263 of thesensor may illuminate the interactant 120 within the breath capturesample cartridge 100 through the lens 112, and the detector 265 maymeasure a color or intensity change produced by the chemical reaction ofthe interactant 120 with the developer solution 175 after the user'sbreath/fluid sample passes through the breath capture sample cartridge100. For example, in the case of acetone, acetone in the user'sbreath/fluid sample may be absorbed by the interactant 120 in the breathcapture sample cartridge 100, and upon the chemical reaction between theinteractant 120 and the developer solution 175, a color change may becaused that can be sensed. The magnitude of this color change may bedependent upon the quantity of acetone absorbed by the interactant 120.

In some embodiments, LEDs 263 of the breath analysis device may serve adual purpose, that is, they may be used as a sensor and for providingvisual indications to a user. In some embodiments, visual indicationsmay include feedback to a user indicating certain actions may need to beperformed and/or are completed (e.g., a breath analysis is complete). Insome embodiments, such dual-use LEDs may illuminate components of thebreath analysis device 200 and/or breath sample capture cartridge 100that are transparent or translucent. In some embodiments, components ofthe breath analysis device 200 that are transparent or translucent mayinclude the slideable door 250, the power switch 290, the mouthpiece300, and the slider button 275. In some embodiments, multiple componentsof the breath sample capture cartridge 100 may be transparent ortranslucent.

Other Variants of a Breath Sample Capture Cartridge

FIGS. 11A-15B illustrate various views of a variant of a breath samplecapture cartridge (which can also be referred to herein as a “breathsample analysis cartridge”) 100 a that may be used to collect a fluidsample, e.g., to collect a fluid sample according to any of the numberof methods disclosed herein and utilizing any of the breath analysissystems and devices described herein. The breath sample capturecartridge 100 a can function the same or similarly to the breath samplecapture cartridge 100. Parts, components, and features of the breathsample capture cartridge 100 a can be the same or similar tocorresponding parts, components, and features of the breath samplecapture cartridge 100. Accordingly, parts, components, and features ofthe breath sample capture cartridge 100 a are identified using the samereference numerals as the corresponding parts, components, and featuresof the breath sample capture cartridge 100, except that a letter “a” hasbeen added to parts, components, and features that may have differences.Such differences are discussed below with respect to FIGS. 11A-15B.

FIGS. 11A-11C show various views of the breath sample capture cartridge100 a. FIG. 11A shows a proximal end perspective view, FIG. 11B shows aproximal end view, and FIG. 11C shows a cross-sectional side view of thebreath sample capture cartridge 100 a. As shown, the breath samplecapture cartridge 100 a can differ from the breath sample capturecartridge 100 by the inclusion of a piston 160 a configured differentlythan the piston 160, and as such aspects of a canister 140 a thatreceives the piston 160 a and that corresponds to canister 140 can beconfigured differently as well. For example, the canister 140 a of thebreath sample capture cartridge 100 a can have an inner wall 141 a,canister channels 142 a, and canister ribs 145 a that are configureddifferently than the corresponding inner wall 141, canister channels142, and canister ribs 145 of the canister 140 of the breath samplecapture cartridge 100. Similar to the breath capture cartridge 100 thathas a proximal end 102 and a distal end 101, the breath sample capturecartridge 100 a has a proximal end 102 a and a distal end 101 a.

Similar to the piston 160, the piston 160 a can be disposed along alongitudinal axis 103 a of the canister 100 a. As shown, the piston 160a can include a main body 166 and a cap 167 that when connected form aninterior volume configured to contain a desiccant, such as a desiccant150 a shown later in FIG. 14C. The main body 166 of the piston 160 a caninclude a proximal portion 168 and a distal portion 169. The cap 167 ofthe piston 160 a can include a generally disc-shaped base 173 with adistal protrusion 176 and a proximal protrusion 162 a, the proximalprotrusion 162 a being similar or the same as the proximal shaftprotrusion 162 of piston 160. The proximal portion 168 of the main body166 can be generally cylindrical with an open proximal end configured toconnect to the distal protrusion 176 of the cap 167, for example, by apress fit. The distal portion 169 of the main body 166 can extenddistally from the proximal portion 168 and can be generally cylindricalhaving a smaller diameter than the proximal portion 168 where it extendsfrom the proximal portion 168 (thus creating a transition in the mainbody 166), a diameter that reduces in the distal direction (e.g., ataper), and a closed distal end. The main body 166 and cap 167 of thepiston 160 a can be molded parts, for example, and be made of a Delrinacetal plastic material.

The main body 166 and/or cap 167 of the piston 160 a can include one ormore openings configured to allow a breath sample to pass therethroughwhile containing the desiccant 150 a within. For example and as shown,the cap 167 can include opening(s) 174, the proximal portion 168 of themain body 166 can include opening(s) 171, and/or the distal portion 169of the main body 166 can include opening(s) 172. The opening(s) 174 ofthe cap 167 can be disposed on the base 173 and open towards theproximal end 102 a of the breath sample capture cartridge 100 a. Asshown, the cap 167 can include four opening(s) 174 spaced evenly apartmidway along a radius of the base 173, however the cap 167 can includeany number of opening(s) 174 with any orientation and spacing. Theopening(s) 171 can be disposed around the proximal portion 168 of themain body 166 and open radially outward (e.g., transverse to thelongitudinal axis 103 a). As shown, the proximal portion 168 can include24 opening(s) 171 arranged in six columns of four openings each andspaced regularly around the proximal portion 168, however the proximalportion 168 can include any number of opening(s) 171 with anyorientation and spacing. The opening(s) 172 can be disposed around thedistal portion 169 of the main body 166 and open radially outward (e.g.,transverse to the longitudinal axis 103 a). As shown, the proximalportion 169 can include four opening(s) 172 arranged in two columns oftwo openings each and spaced regularly around the distal portion 169,however the distal portion 169 can include any number of opening(s) 172with any orientation and spacing. As mentioned, the opening(s) 174, 171,and 172 can be configured to contain a desiccant, and as such they canbe sized and/or shaped to prevent such desiccant from escaping thecage-like and/or basket-like structure of the piston 160 a. Theopening(s) 174 can be sized and/or shaped the same or differently. Theopening(s) 171 can be sized and/or shaped the same or differently. Theopening(s) 172 can be sized and/or shaped the same or differently. Theopening(s) 174, 171, and 172 can be sized and/or shaped the same ordifferently from each other.

The piston 160 a can have a longitudinal length of about 0.65inches±0.15 inches. Furthermore, the piston 160 a can have an internalvolume (e.g., for receiving desiccant 150 a) preferably in the range ofabout 0.006 cubic inches to about 0.018 cubic inches, more preferably inthe range of about 0.009 cubic inches to about 0.015 cubic inches, forexample, about 0.012 cubic inches. The cap 167 can have a longitudinallength of about 0.13 inches±0.06 inches and a maximum outer diameter ofabout 0.33 inches±0.06 inches. The main body 166 can have a longitudinallength of about 0.48 inches±0.06 inches. The proximal portion 168 of themain body 166 can have an outer diameter of about 0.29 inches±0.06inches, an inner diameter of about 0.23 inches±0.06 inches, and alongitudinal depth (e.g., from its proximal end to where it cantransition to the distal portion 169) of about 0.22 inches±0.06 inches.The distal portion 169 of the main body 166 can have an outer diameterof about 0.22 inches±0.06 inches, an inner diameter of about 0.09inches±0.06 inches, and a longitudinal length of about 0.08 inches±0.06inches. The proximal portion 168 and/or the distal portion 169 can haveinner diameters that reduce in the distal direction to aid inmanufacturability (e.g., the internal features can be drafted to aid inmoldability).

In regard to the flow path of a fluid sample within the breath samplecapture cartridge 100 a, it can be understood with reference to FIG. 11Cthat in at least one embodiment, a continuous flow path proceeds fromthe proximal end 102 a of the breath sample capture cartridge 100 a,into the opening(s) 174 of the cap 167 of the piston 160 a, through adesiccant held by the piston 160 a (not shown in FIG. 11C but shown inFIG. 14C), through the opening(s) 171 of the proximal portion 168 of thepiston 160 a, through the one or more channels 142 a, through theintermediate layer if included (not shown in FIG. 11C), through theporous structure base 134 of the porous structure 130, through theinteractant 120, through the sides of the porous structure 130, and outthrough the lens cap vents 114. In some embodiments, a continuous flowpath of a fluid sample proceeds from the proximal end 102 a of thebreath sample capture cartridge 100 a, into the opening(s) 174 of thecap 167 of the piston 160 a, through a desiccant held by the piston 160a (not shown in FIG. 11C but shown in FIG. 14C), through the opening(s)172 of the distal portion 169 of the piston 160 a, through the one ormore channels 142 a, through the intermediate layer if included (notshown in FIG. 11C), through the porous structure base 134 of the porousstructure 130, through the interactant 120, through the sides of theporous structure 130, and out through the lens cap vents 114. In somecases, a continuous flow path of a fluid sample proceeds as the userexhales into the breath analysis device from the proximal end 102 a ofthe breath sample capture cartridge 100 a, into the one or more channels142 a of the canister 140 a, through the one or more channels 142 a,through the intermediate layer if included (not shown in FIG. 11C),through the porous structure base 134 of the porous structure 130,through the interactant 120, through the sides of the porous structure130, and out through the lens cap vents 114. Of course, one of ordinaryskill in the art will understand that various modifications to the flowpath(s) may be made.

FIGS. 12A-12B show exploded views of the breath sample capture cartridge100 a. As shown, the breath sample capture cartridge 100 a can include alens cap 110 including a lens cap cover 111 and a lens cap body 113, aporous structure 130, a reservoir 170, a canister 140 a, a piston 160 a,a desiccant 150 a, and a decal 105.

FIGS. 13A-13H show various views of the canister 140 a of the breathsample capture cartridge 100 a. FIGS. 13A-13B show distal endperspective views, FIGS. 13C-13D show proximal end perspective views,FIG. 13E shows a distal end view, FIG. 13F shows a proximal end view,FIG. 13G shows a side view, and FIG. 13H shows a cross-sectional sideview of the canister 140 a. As can be seen in the various views of FIGS.13A-13H, the canister 140 a can have the same or similar parts,components, and features as the canister 140 described herein and canfunction the same or similarly as the canister 140. The canister 140 acan comprise a substantially cylindrical shape with a canister cavity144 a formed by the inner wall 141 a of the canister 140 a. The canistermay include one or more channels 142 a separated by a plurality of ribs145 a extending radially inwardly from the inner wall 141 a. The one ormore channels 142 a may allow for the entry and passage of the samplefluid into and through the breath sample capture cartridge 100 a towardsthe porous structure 130 and the interactant 120 it may contain.Therefore, the one or more channels 142 a may advantageously havecharacteristics (e.g., shape, size, direction, etc.) that promotethorough and efficient mixing of the sample fluid with the interactant120 contained within the porous structure 130. In some embodiments, suchefficient mixing is achieved by inducing turbulent flow of the samplefluid. In some embodiments, the channels 142 a are shaped, arranged, andoriented to increase the turbulence of fluid flow and/or mixing of thesample fluid with the interactant 120 contained in the porous structure130. In some embodiments, the one or more channels 142 a comprises aplurality of channels, e.g., 8 channels, or any other number of channels142 a that promotes fluid flow through the breath sample capturecartridge 100 a and efficient mixing of the sample fluid with theinteractant 120 contained in the porous structure 130.

The plurality of ribs 145 a of the cannister 140 a may comprise variousradially inward protrusions along their length, including a proximalprotrusion 146 a, a mid-proximal protrusion 147 a, a mid-distalprotrusion 148 a, and/or a distal protrusion 149 a. In some embodimentsand as shown, the canister can include 8 ribs 145 a, the 8 ribs 145 aincluding two proximal protrusions 146 a, two mid-proximal protrusions147 a, four mid-distal protrusions 148 a, and four distal protrusions149 a. Further as shown, a rib 145 a that includes a proximal protrusion146 a or a mid-proximal protrusion 147 a may not include any furtherprotrusions along its length, while a rib 145 a that contains amid-distal protrusion 148 a may also include a distal protrusion 149 aalong its length. A proximal protrusion 146 a may comprise a ramped orcurved proximal-facing end and a shelf-like distal-facing end. Likewise,a mid-proximal protrusion 147 a may comprise a ramped or curvedproximal-facing end and a shelf-like distal-facing end. A mid-distalprotrusion 148 a may comprise a ramped, curved, or shelf-likeproximal-facing end, and a distal protrusion 149 a may comprise ashelf-like proximal-facing end. The various potential interactions ofthe ribs 145 a with protrusions 146 a, 147 a, 148 a, and 149 a withother components of the breath sample capture cartridge will bedescribed later herein, particularly in reference to FIGS. 15A-15B. Ofcourse, one of ordinary skill in the art will understand that variousmodifications to the number and orientation of the protrusions and ribsmay be made compared to the embodiment shown in FIGS. 13A-13H.

FIGS. 14A-14B show proximal end and distal end perspective views of thepiston 160 a in relation to the reservoir 170 of the breath samplecapture cartridge 100 a. As shown, the reservoir 170 can be disposeddistal to the distal portion 169 of the piston 160 a.

FIG. 14C shows a distal end perspective exploded view of the piston 160a in relation to a desiccant 150 a. As shown, the cap 167 is unconnectedfrom the main body 166 of the piston 160 a and the desiccant 150 a isdisposed within the interior volume of the main body 166. Similar to thedesiccant 150, the desiccant 150 a can comprise a fibrous and/orabsorbent material that can absorb moisture from the fluid sample. Forexample, the desiccant 150 a can include cotton and/or a high releasemedia such as PE and/or PP. Alternatively, or in addition, the desiccant150 a can include a molecular sieve 4A material (which can be encased inthe polymer Tyvek), calcium chloride, and/or calcium sulfate. As shown,the desiccant 150 a can comprise a loose absorbent material that can bepacked into the interior volume of the piston 160 a. The desiccant 150 acan fill the entire interior volume of the piston 160 a or it maypartially fill the interior volume of the piston 160 a. As an example,for a molecular sieve 4A material, the total mass of desiccant 150 athat can fill the piston 160 a can be approximately 0.14 grams. Theopening(s) 174, 171, and 172 of the piston 160 a can advantageously beshaped and/or sized to substantially contain the desiccant 150 a whilealso allowing for fluid flow therethrough and interaction of the fluidsample with the desiccant 150 a. Continuing with the example of amolecular sieve 4A material for desiccant 150 a (in this case encased inthe polymer Tyvek), such desiccant 150 a can have an average diameter ofabout 1.4 mm, a minimum particle size of about 1.21 mm, a maximumparticle size of about 1.74 mm, and a standard deviation of about 0.17mm.

FIGS. 15A-15B show cross-sectional views of the breath sample capturecartridge 100 a with the piston 160 a at two positions along thelongitudinal axis 103 a of the breath sample capture cartridge 100 awith the desiccant 150 a and the reservoir 170 removed from view. FIG.15A shows the piston 160 a in a first position, which may correspond toa breath sample capture cartridge 100 a in an unused and/or new state.FIG. 15B shows the piston 160 a in a second position advanced distallyalong longitudinal axis 103 a within the breath sample capture cartridge100 a, which may correspond to a breath sample capture cartridge 100 ain a used and/or activated state.

As shown in FIG. 15A, in some embodiments the piston 160 a may be heldrelatively in place in the first position by interaction of the proximalside of the base 173 of cap 167 of piston 160 a with the shelf-likedistal-facing end of proximal protrusion 146 a of a rib 145 a of thecanister 140 a and the distal side of the base 173 with the ramped orcurved proximal-facing end of mid-proximal protrusion 147 a hidden fromview in FIG. 15A but seen in FIG. 15B) of a rib 145 a. For example, thepiston 160 a may be prevented from translating substantially distally orproximally by the interaction of the base 173 with protrusions 146 a and147 a of ribs 145 a.

As shown in FIG. 15B, in the process of a user obtaining a breath sampleanalysis as described herein, the piston 160 a may be translateddistally along the longitudinal axis 103 a of the breath sample capturecartridge 100 a to a second position. To translate distally, alongitudinal force in the distal direction may be applied to the piston160 a at its proximal end, such as to and/or around proximal protrusion162 a, to cause the base 173 of piston 160 a to slide over the ramped orcurved proximal-facing end of mid-proximal protrusion 147 a andsubstantially lock into place within the breath sample capture cartridge100 a. To lock in place, the proximal side of the base 173 may interactwith the shelf-like distal-facing end of mid-proximal protrusion 147 a.As such, once a user causes distal translation of the piston 160 awithin the breath sample cartridge 100 a, sustained force may not berequired to keep the piston 160 a in the second position. In someembodiments, distal translation of piston 160 a within the breath samplecartridge 100 a may be limited by interaction between the shelf-likeproximal-facing end of distal protrusion 149 a with the main body 166 ofpiston 160 a and/or interaction between the ramped, curved, orshelf-like proximal-facing end of mid-distal protrusion 148 a with themain body 166. As described for the piston 160 of the breath samplecapture cartridge 100, distal translation of the piston 160 a within thebreath sample capture cartridge 100 a can cause the developer solution175 of the reservoir 170 to pass through the porous structure 130supporting the interactant 120 and come into contact with theinteractant 120.

While a desiccant within a breath sample capture cartridge can beutilized to absorb moisture from and/or dehumidify a fluid sample passedthrough the breath sample capture cartridge, such as desiccant 150 inbreath sample capture cartridge 100 and/or desiccant 150 a in breathsample capture cartridge 100 a, the desiccant can also be utilized forother purposes. For example, the desiccant 150 and/or 150 a can beutilized to absorb residual moisture within a packaging of itsrespective breath sample capture cartridge 100 and/or 100 a. As anotherexample, the desiccant 150 and/or 150 a can be utilized to preserve thechemistry of the interactant while in packaging and/or storage.

The foregoing description and examples has been set forth merely toillustrate the disclosure and are not intended as being limiting. Eachof the disclosed aspects and embodiments of the present disclosure maybe considered individually or in combination with other aspects,embodiments, and variations of the disclosure. In addition, unlessotherwise specified, none of the steps of the methods of the presentdisclosure are confined to any particular order of performance.Modifications of the disclosed embodiments incorporating the spirit andsubstance of the disclosure may occur to persons skilled in the art andsuch modifications are within the scope of the present disclosure.Furthermore, all references cited herein are incorporated by referencein their entirety.

Terms of orientation used herein, such as “top,” “bottom,” “horizontal,”“vertical,” “longitudinal,” “lateral,” and “end” are used in the contextof the illustrated embodiment. However, the present disclosure shouldnot be limited to the illustrated orientation. Indeed, otherorientations are possible and are within the scope of this disclosure.Terms relating to circular shapes as used herein, such as diameter orradius, should be understood not to require perfect circular structures,but rather should be applied to any suitable structure with across-sectional region that can be measured from side-to-side. Termsrelating to shapes generally, such as “circular” or “cylindrical” or“semi-circular” or “semi-cylindrical” or any related or similar terms,are not required to conform strictly to the mathematical definitions ofcircles or cylinders or other structures, but can encompass structuresthat are reasonably close approximations.

Conditional language used herein, such as, among others, “can,” “might,”“may,” “e.g.,” and the like, unless specifically stated otherwise, orotherwise understood within the context as used, is generally intendedto convey that some embodiments include, while other embodiments do notinclude, certain features, elements, and/or states. Thus, suchconditional language is not generally intended to imply that features,elements, blocks, and/or states are in any way required for one or moreembodiments or that one or more embodiments necessarily include logicfor deciding, with or without author input or prompting, whether thesefeatures, elements and/or states are included or are to be performed inany particular embodiment.

Conjunctive language, such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount close to the stated amount that still performs adesired function or achieves a desired result. For example, in someembodiments, as the context may dictate, the terms “approximately”,“about”, and “substantially” may refer to an amount that is within lessthan or equal to 10% of the stated amount. The term “generally” as usedherein represents a value, amount, or characteristic that predominantlyincludes or tends toward a particular value, amount, or characteristic.As an example, in certain embodiments, as the context may dictate, theterm “generally parallel” can refer to something that departs fromexactly parallel by less than or equal to 20 degrees.

Where term “about” is utilized before a range of two numerical values,this is intended to include a range between about the first value andabout the second value, as well as a range from the first valuespecified to the second value specified.

Unless otherwise explicitly stated, articles such as “a” or “an” shouldgenerally be interpreted to include one or more described items.Accordingly, phrases such as “a device configured to” are intended toinclude one or more recited devices. Such one or more recited devicescan be collectively configured to carry out the stated recitations. Forexample, “a processor configured to carry out recitations A, B, and C”can include a first processor configured to carry out recitation Aworking in conjunction with a second processor configured to carry outrecitations B and C.

The terms “comprising,” “including,” “having,” and the like aresynonymous and are used inclusively, in an open-ended fashion, and donot exclude additional elements, features, acts, operations, and soforth. Likewise, the terms “some,” “certain,” and the like aresynonymous and are used in an open-ended fashion. Also, the term “or” isused in its inclusive sense (and not in its exclusive sense) so thatwhen used, for example, to connect a list of elements, the term “or”means one, some, or all of the elements in the list.

Overall, the language of the claims is to be interpreted broadly basedon the language employed in the claims. The language of the claims isnot to be limited to the non-exclusive embodiments and examples that areillustrated and described in this disclosure, or that are discussedduring the prosecution of the application.

Although systems, devices, components, and methods for breathcollection, sampling, segmentation, and analysis have been disclosed inthe context of certain embodiments and examples, this disclosure extendsbeyond the specifically disclosed embodiments to other alternativeembodiments and/or uses of the embodiments and certain modifications andequivalents thereof. Various features and aspects of the disclosedembodiments can be combined with or substituted for one another in orderto form varying modes of systems and methods for breath collection,sampling, segmentation, and analysis. The scope of this disclosureshould not be limited by the particular disclosed embodiments describedherein.

Certain features that are described in this disclosure in the context ofseparate implementations can be implemented in combination in a singleimplementation. Conversely, various features that are described in thecontext of a single implementation can be implemented in multipleimplementations separately or in any suitable subcombination. Althoughfeatures may be described herein as acting in certain combinations, oneor more features from a claimed combination can, in some cases, beexcised from the combination, and the combination may be claimed as anysubcombination or variation of any subcombination.

While the methods and devices described herein may be susceptible tovarious modifications and alternative forms, specific examples thereofhave been shown in the drawings and are herein described in detail. Itshould be understood, however, that the invention is not to be limitedto the particular forms or methods disclosed, but, to the contrary, theinvention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the various embodiments describedand the appended claims. Further, the disclosure herein of anyparticular feature, aspect, method, property, characteristic, quality,attribute, element, or the like in connection with an embodiment can beused in all other embodiments set forth herein. Any methods disclosedherein need not be performed in the order recited. Depending on theembodiment, one or more acts, events, or functions of any of thealgorithms, methods, or processes described herein can be performed in adifferent sequence, can be added, merged, or left out altogether (e.g.,not all described acts or events are necessary for the practice of thealgorithm). In some embodiments, acts or events can be performedconcurrently, e.g., through multi-threaded processing, interruptprocessing, or multiple processors or processor cores or on otherparallel architectures, rather than sequentially. Further, no element,feature, block, or step, or group of elements, features, blocks, orsteps, are necessary or indispensable to each embodiment. Additionally,all possible combinations, subcombinations, and rearrangements ofsystems, methods, features, elements, modules, blocks, and so forth arewithin the scope of this disclosure. The use of sequential, ortime-ordered language, such as “then,” “next,” “after,” “subsequently,”and the like, unless specifically stated otherwise, or otherwiseunderstood within the context as used, is generally intended tofacilitate the flow of the text and is not intended to limit thesequence of operations performed. Thus, some embodiments may beperformed using the sequence of operations described herein, while otherembodiments may be performed following a different sequence ofoperations.

Moreover, while operations may be depicted in the drawings or describedin the specification in a particular order, such operations need not beperformed in the particular order shown or in sequential order, and alloperations need not be performed, to achieve the desirable results.Other operations that are not depicted or described can be incorporatedin the example methods and processes. For example, one or moreadditional operations can be performed before, after, simultaneously, orbetween any of the described operations. Further, the operations may berearranged or reordered in other implementations. Also, the separationof various system components in the implementations described hereinshould not be understood as requiring such separation in allimplementations, and it should be understood that the describedcomponents and systems can generally be integrated together in a singleproduct or packaged into multiple products. Additionally, otherimplementations are within the scope of this disclosure.

Some embodiments have been described in connection with the accompanyingfigures. Certain figures are drawn and/or shown to scale, but such scaleshould not be limiting, since dimensions and proportions other than whatare shown are contemplated and are within the scope of the embodimentsdisclosed herein. Distances, angles, etc. are merely illustrative and donot necessarily bear an exact relationship to actual dimensions andlayout of the devices illustrated. Components can be added, removed,and/or rearranged. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with various embodiments can be usedin all other embodiments set forth herein. Additionally, any methodsdescribed herein may be practiced using any device suitable forperforming the recited steps.

The methods disclosed herein may include certain actions taken by apractitioner; however, the methods can also include any third-partyinstruction of those actions, either expressly or by implication. Forexample, actions such as “positioning an electrode” include “instructingpositioning of an electrode.”

In summary, various embodiments and examples of systems and methods forbreath collection, sampling, segmentation, and analysis have beendisclosed. Although the systems and methods for breath collection,sampling, segmentation, and analysis have been disclosed in the contextof those embodiments and examples, this disclosure extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or other uses of the embodiments, as well as to certainmodifications and equivalents thereof. This disclosure expresslycontemplates that various features and aspects of the disclosedembodiments can be combined with, or substituted for, one another. Thus,the scope of this disclosure should not be limited by the particulardisclosed embodiments described herein, but should be determined only bya fair reading of the claims that follow.

The ranges disclosed herein also encompass any and all overlap,sub-ranges, and combinations thereof. Language such as “up to,” “atleast,” “greater than,” “less than,” “between,” and the like includesthe number recited. Numbers preceded by a term such as “about” or“approximately” include the recited numbers and should be interpretedbased on the circumstances (e.g., as accurate as reasonably possibleunder the circumstances, for example ±5%, ±10%, ±15%, etc.). Forexample, “about 1 V” includes “1 V.” Phrases preceded by a term such as“substantially” include the recited phrase and should be interpretedbased on the circumstances (e.g., as much as reasonably possible underthe circumstances). For example, “substantially perpendicular” includes“perpendicular.” Unless stated otherwise, all measurements are atstandard conditions including temperature and pressure.

What is claimed is:
 1. A breath sample analysis cartridge, comprising: acartridge body that houses an interactant and a compressible reservoirthat holds a volume of developer solution, said compressible reservoircomprising an absorbent material pre-soaked with said developersolution; and a piston slidably mounted within the cartridge body, thepiston slidable from a first position in which the piston does not applya compressive force to the compressible reservoir to a second positionin which the piston applies a compressive force to the compressiblereservoir, wherein the compressive force causes the developer solutionto flow from the compressible reservoir into the interactant; whereinthe piston and cartridge body are configured to cause the piston to lockinto said second position such that the piston continues to apply saidcompressive force to the compressible reservoir once the piston isadvanced to the second position.
 2. The breath sample analysis cartridgeof claim 1, in combination with a breath analysis device configured toreceive the cartridge, the breath analysis device comprising amouthpiece and configured to route a breath sample exhaled into themouthpiece through the cartridge, the breath analysis device furthercomprising an optical sensor configured to measure a color change in thecartridge.
 3. The breath sample analysis cartridge of claim 1, whereinan interior portion of the cartridge body comprises a protrusion thatengages with the piston to cause the piston to become locked in thesecond position.
 4. A breath sample analysis cartridge, comprising: acartridge body that houses an interactant and a compressible reservoirthat holds a volume of developer solution; and a piston slidably mountedwithin the cartridge body, the piston slidable from a first position inwhich the piston does not apply a compressive force to the compressiblereservoir to a second position in which the piston applies a compressiveforce to the compressible reservoir, wherein the compressive forcecauses the developer solution to flow from the compressible reservoirinto the interactant, wherein the piston carries a desiccant; whereinthe piston and cartridge body are configured to cause the piston to lockinto said second position such that the piston continues to apply saidcompressive force to the compressible reservoir once the piston isadvanced to the second position.
 5. The breath sample analysis cartridgeof claim 4, wherein the desiccant is contained in a basket portion ofthe piston.
 6. The breath sample analysis cartridge of claim 4, whereinthe cartridge is configured such that a breath sample that enters aproximal end of the cartridge body passes through the desiccant beforeflowing through the interactant.
 7. A breath sample analysis cartridge,comprising: a cartridge body that houses an interactant and acompressible reservoir that holds a volume of developer solution, saidcompressible reservoir comprising an absorbent material soaked with saiddeveloper solution; and a slidable member slidably mounted within thecartridge body, the slidable member slidable from a first position inwhich the slidable member does not apply a compressive force to thecompressible reservoir to a second position in which the slidable memberapplies a compressive force to the compressible reservoir, wherein thecompressive force causes the developer solution to flow from thecompressible reservoir into the interactant; wherein the slidable memberlocks into said second position in the cartridge body.
 8. The breathsample analysis cartridge of claim 7, wherein the cartridge isconfigured such that a breath sample that enters a proximal end of thecartridge body flows through the desiccant before flowing through theinteractant.
 9. The breath sample analysis cartridge of claim 7, incombination with a breath analysis device configured to receive thecartridge, the breath analysis device comprising a mouthpiece andconfigured to route a breath sample exhaled into the mouthpiece throughthe cartridge, the breath analysis device further comprising an opticalsensor configured to measure a color change in the cartridge.
 10. Thebreath sample analysis cartridge and breath analysis device of claim 9,wherein the breath analysis device is configured to apply a force thatcauses the slidable member to move from the first position to the secondposition.
 11. The breath sample analysis cartridge of claim 7, whereinthe compressible reservoir is formed from a fibrous material.
 12. Abreath sample analysis cartridge, comprising: a cartridge body thathouses an interactant and a compressible reservoir that holds a volumeof developer solution; and a slidable member slidably mounted within thecartridge body, the slidable member slidable from a first position inwhich the slidable member does not apply a compressive force to thecompressible reservoir to a second position in which the slidable memberapplies a compressive force to the compressible reservoir, wherein thecompressive force causes the developer solution to flow from thecompressible reservoir into the interactant, wherein the slidable membercarries a desiccant; p1 wherein the slidable member locks into saidsecond position in the cartridge body.
 13. The breath sample analysiscartridge of claim 12, wherein the desiccant is contained in a basketportion of the slidable member.